TRANSMITTED BY FACSIMILE
|
|
- Rodney Walton
- 5 years ago
- Views:
Transcription
1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD TRANSMITTED BY FACSIMILE Kirsten Dale Manager, Regulatory Affairs Promotion/Advertising One Takeda Parkway Deerfield, IL RE: NDA # Rozerem TM (ramelteon) Tablets MACMIS # Dear Ms. Dale: The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a Substance Abuse Patient Profile Sell Sheet (RAM-01071) (Sell Sheet) for Rozerem TM (ramelteon) Tablets (Rozerem) submitted by (Takeda) under cover of Form FDA The Sell Sheet is false or misleading because it makes unsubstantiated superiority presentations, omits and minimizes the risks associated with the use of Rozerem, omits material facts, and makes a misleading claim about Rozerem. The Sell Sheet thus misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations. See 21 CFR 201.6(a); cf. 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(ii) & (e)(7)(viii). Background According to its FDA-approved product labeling (PI), 1 ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem is also associated with numerous risks. The PI contains contraindications for patients who are hypersensitive to Rozerem or any component of the product. The PI also contains a warning for careful evaluation of patients with sleep disturbances, the need for evaluation of primary psychiatric and/or medical illness if insomnia fails to remit after a reasonable period of treatment, as well as worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, as such symptoms may be the presenting manifestation of a physical and/or psychiatric disorder. The PI also contains warnings pertaining to use in patients with severe hepatic impairment, use in combination with fluvoxamine, cognitive and behavioral changes (including worsening of depression and suicidal ideation in primarily depressed patients), engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery), and confining 1 The PI disseminated with the Sell Sheet, and referred to in this letter, was dated August 18, Although not relevant to the content of this letter, the most recent version of the PI was revised and approved on October 20, 2008.
2 Kirsten Dale Page 2 activities after taking Rozerem to those necessary to prepare for bed. Furthermore, the PI contains precautions against use in patients with severe sleep apnea or severe chronic obstructive pulmonary disease (COPD), use in combination with alcohol, and effects on reproductive hormones in adults (e.g., decreased testosterone levels and increased prolactin levels). In general, the most common adverse reactions with at least 2% incidence difference relative to placebo include somnolence (5% vs. 3%), fatigue (4% vs. 2%), and dizziness (5% vs. 3%). The DOSAGE AND ADMINISTRATION section of the PI states that Rozerem should be taken within 30 minutes of going to bed and should not be taken with or immediately after a high-fat meal. Similar to the precautions cited in the PI, the DOSAGE AND ADMINISTRATION section reiterates that Rozerem should not be used in subjects with severe hepatic impairment, and Rozerem should be used with caution in patients with moderate hepatic impairment. In addition, the PI states that Rozerem should not be used in combination with fluvoxamine, nor should it be used in patients taking other CYP1A2 inhibiting drugs. Unsubstantiated Superiority Presentation/Minimization of Risk Information Promotional materials are misleading if they contain a drug comparison that represents or suggests that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience. The third page of the Sell Sheet presents the following claims and presentation (bolded emphasis in original; underlined emphasis added; footnotes omitted): Rozerem is the only prescription insomnia medication with no evidence of abuse potential... In a meta-analysis report evaluating abuse liability of 19 hypnotic compounds, only Rozerem demonstrated no likelihood of abuse and no detectable toxicity. The above claims are presented in conjunction with a bar graph titled, RELATIVE ABUSE LIABILITY OF 19 HYPNOTIC DRUGS (footnote omitted), which shows Likelihood of abuse and Toxicity scores for various hypnotic drugs. The bar graph shows varying scores of likelihood of abuse and toxicity for 18 drugs, and Rozerem is shown to have a score of zero for both measurements. The above presentation suggests that Rozerem has no likelihood of abuse and no toxicity, in contrast to the other 18 sedatives/hypnotics presented, and is therefore superior to these other drug products. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Rozerem has no likelihood of abuse and no detectable toxicity compared to the listed drug products. The reference 2 cited to support this presentation assigned relative abuse liability categorized by likelihood of abuse and toxicity based on an across label comparison of Rozerem to the other 18 drugs listed in the above referenced bar graph. An across label comparison does not constitute substantial evidence or substantial clinical experience to support the above claims and presentation. We 2 Griffiths RR, Johnson MW. Relative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compounds. J. Clin. Psychiatry. 2005;66(suppl 9):31-41.
3 Kirsten Dale Page 3 acknowledge the inclusion of the footnote at the bottom of the page, Results of a metaanalysis, not a head-to-head study... ; however, this statement is insufficient to mitigate the misleading implication that Rozerem is superior to other sedative/hypnotic drugs with respect to the likelihood of abuse and toxicity, and that it is safer than has been demonstrated. Furthermore, this presentation minimizes the risks associated with the use of Rozerem by implying that Rozerem has no toxicity associated with its use. This presentation is particularly concerning because Rozerem is associated with numerous risks, including potential endocrine toxicity. This presentation also fails to disclose any information about other attributes of Rozerem therapy, including serious risks that are highly material to any decision about whether to prescribe Rozerem or another sedative hypnotic. This presentation is also misleading because it suggests Rozerem is a superior prescription insomnia medication as compared to all the products listed; however the FDA-approved indications for the products depicted in the bar graph are not the same across all products. In fact, several of the drugs (e.g., trazodone, diazepam, and oxazepam) are not FDA-approved for the treatment of insomnia. Furthermore, two of the products listed, flunitrazepam and methaqualone, are not currently approved for any use in the United States. This presentation misleadingly fails to reveal the differences in indications of the products being compared. In addition, the totality of the claims and presentations on the first page of the Sell Sheet misleadingly imply that Rozerem is a superior insomnia treatment option for substance abuse patients compared to the other sedative/hypnotic drugs based solely on the referenced drugs attributes as benzodiazepine receptor agonists or Schedule IV controlled substances. It is misleading to imply that, based solely on these two attributes, Rozerem is a superior treatment option for these patients. This presentation omits material information about other attributes of Rozerem therapy, including serious risks, which are highly relevant to any decision about whether to prescribe Rozerem or another sedative hypnotic. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Rozerem is safer, more effective, or otherwise superior to the other sedatives/hypnotics listed on the first page of the Sell Sheet. Generally, adequate and well-controlled head-to-head comparative studies are necessary to support claims of superiority. Omission and Minimization of Risk Information Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. Promotional materials are also misleading if they fail to present information about risks associated with a drug with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of the drug. The first three pages of the four-page Sell Sheet contain numerous benefit claims for Rozerem, but fail to convey any risk information on these pages. The only specific risk disclosure is relegated to the back cover of the Sell Sheet. In stark contrast to the efficacy claims in the piece, which are presented with colorful tables and graphs, bolded headers, bullets, and use of a significant amount of white space, the risk presentation on the back cover is presented in small font and in single-spaced, paragraph format. As such, this
4 Kirsten Dale Page 4 presentation fails to present risk information with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of the drug. Furthermore, this presentation fails to disclose important risk information associated with Rozerem, including WARNING information from the PI about engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery). This risk presentation also minimizes some of the risks that are disclosed. Specifically, the risk presentation states, Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression. However, according to the WARNINGS section of the PI, In primarily depressed patients, worsening of depression, including suicidal ideation, has been reported in association with the use of hypnotics (emphasis added). By failing to present this information pertaining to suicidality, the Sell Sheet misleadingly suggests that Rozerem is safer than has been demonstrated. Additionally, the Sell Sheet includes the tagline, Proven for sleep. Nonscheduled for added safety (italicized emphasis in original; bolded emphasis added). This claim minimizes the risks associated with Rozerem by suggesting that Rozerem is safer than other sedatives/hypnotics merely because it is not scheduled by the U.S. Drug Enforcement Administration (DEA). As noted above, Rozerem is associated with numerous risks. Its attribute as a nonscheduled drug does not alone confer added safety. Omission of Material Facts Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The header on the back cover of the Sell Sheet includes the claim, You can prescribe Rozerem for as long as you need to (emphasis in original) with the following footnote, Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem can be prescribed for long-term use. This claim misleadingly omits important contextual information regarding the long-term use of Rozerem. As stated in the WARNINGS section of the PI, The failure of insomnia to remit after a reasonable period of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient. We acknowledge that the Important safety information section of the Sell Sheet contains the following information, Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. However, this sentence, which is buried in the risk presentation on the back cover of the piece, is not sufficient to provide context for the prominent long-term use claim. Misleading Claim The Sell Sheet includes the following claim, One simple 8-mg dose (emphasis in original; footnote omitted). This claim misleadingly implies that Rozerem s dosing is simple, when this has not been proven with adequate evidence. As described in the DOSING AND ADMINISTRATION section of the PI, Rozerem dosing is associated with detailed instructions
5 Kirsten Dale Page 5 for use and multiple limitations and considerations (see Background section above). Such limitations and considerations do not support simple dosing of Rozerem. FDA is unaware of any adequate evidence to support a claim that Rozerem dosing is simple. If you have data to support this claim, please submit them to FDA for review. Conclusion and Requested Action For the reasons discussed above, the Sell Sheet misbrands Rozerem under the Act, 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations. See 21 CFR 201.6(a); cf. 21 CFR 202.1(e)(3)(i); (e)(5); (e)(6)(ii) & (e)(7)(viii). DDMAC requests that Takeda immediately cease the dissemination of violative promotional materials for Rozerem such as those described above. Please submit a written response to this letter on or before February 11, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Rozerem that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at (301) In all future correspondence regarding this matter, please refer to MACMIS #17711 in addition to the NDA number. We remind you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Rozerem comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely, {See appended electronic signature page} Sheetal Patel, Pharm.D. Regulatory Review Officer Amy Toscano, Pharm.D., CPA Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
6 Application Type/Number Submission Type/Number Submitter Name Product Name NDA ORIG-1 TAKEDA GLOBAL ROZEREM RESEARCH DEVELOPMENT CENTER INC This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature /s/ SHEETAL PATEL 01/28/2010 AMY TOSCANO 01/28/2010
According to the INDICATIONS AND USAGE section of its FDA-approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Karen L. Walles, M.S. Assistant Director, Regulatory Affairs 3
More informationAccording to the Indications and Usage section of the approved product labeling (PI): 1
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE George Marchesini Associate Director, Global Regulatory Affairs
More informationBelow is the indication and summary of the most serious and most common risks associated with the use of Naftin Cream, 2%. 2
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Misty M. D Ottavio, Senior Manager Regulatory Affairs 4215 Tudor
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Carole S. Ben-Maimon, M.D. President and Chief Operating Officer One
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE David E.I. Pyott Chairman of the Board and Chief Executive Officer
More informationWARNING LETTER TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE John Lechleiter, Ph.D. President & Chief Executive Officer Eli Lilly
More informationJohn C. Kim, RPh, JD Senior Director, Regulatory Affairs Ferring Pharmaceuticals Inc. 4 Gatehall Drive 3 rd Floor Parsippany, NJ 07054
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 John C. Kim, RPh, JD Senior Director, Regulatory Affairs Ferring Pharmaceuticals Inc. 4
More informationRE: NDA # Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets MACMIS # 18360
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Joyce Q. Acbay Director, Regulatory Affairs 333 Lakeside Drive
More informationBrian Deutsch Associate, Regulatory Affairs Warner Chilcott (US), LLC 100 Enterprise Drive Rockaway, NJ 07866
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Brian Deutsch Associate, Regulatory Affairs 100 Enterprise Drive
More informationLevitra According to its FDA-approved product labeling (PI), Levitra is indicated for the treatment of erectile dysfunction.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly Associate Director, Global Regulatory Affairs Bayer
More informationBelow are the indication (in pertinent part) and summary of the most serious and most common risks associated with the use of Tindamax.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Eric White Senior Vice President Regulatory Affairs & Quality Assurance 10999 Interstate
More informationWARNING LETTER. Robert Essner Chairman and Chief Executive Officer Wyeth Pharmaceuticals Inc. P.O. Box 8299 Philadelphia, PA
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Robert Essner Chairman and Chief Executive Officer P.O. Box 8299 Philadelphia,
More informationWARNING LETTER. ( (last accessed July 10, 2009).
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Miles D. White Chairman of the Board & Chief Executive Officer
More informationMichelle Sharp, PharmD Director, US Regulatory Affairs Lilly Corporate Center Indianapolis, IN 46285
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Michelle Sharp, PharmD Director, US Regulatory Affairs Lilly Corporate
More informationAccording to the Indications and Usage section of the FDA-approved product labeling (PI) 1 :
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Rexner Vargas, Senior Manager, Regulatory Affairs Amylin Pharmaceuticals,
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Henry A. McKinnell, Jr., Ph.D. Chairman of the Board and Chief Executive
More informationWARNING LETTER TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Samuel D. Waksal, Ph.D. Chairman and Chief Executive Officer 119
More information,~~~ WARNING LETTER. Frank Baldino, Jr., Ph.D. Chairman and Chief Executive Officer Cephalon, Inc. 41 Moores Road P.O. Box 4011 Frazer, PA USA
'>~,,~..t'~\i'icl"$_.(,~ ( -i1f!..department OF HEALTIl & HUMAN SERVICES,~~~ Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Frank Baldino, Jr., Ph.D. Chairman
More informationWARNING LETTER. According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI)' for Tykerb:
EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Chief Executive Officer GlaxoSmithKline P.O. Box 13398 Five Moore
More informationRandy Russell Assistant Director, Regulatory Affairs Alcon Research, Ltd South Freeway, R3-54 Fort Worth, TX
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Randy Russell Assistant Director, Regulatory Affairs 6201 South Freeway, R3-54 Fort Worth,
More informationWARNING LETTER. According to the Indications and Usage section of the FDA approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE David E.I. Pyott President and Chief Executive Officer PO Box 19534
More informationWARNING LETTER. ( (ORA05050) for OrapredCI (prednisolone sodium phosphate
+t-tlserviçès-,& v,ù',' : -::~.,'" ( -ldepartment OF HEALTH & HUMAN SERVICES 'P"~~\- Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE October 11, 2006 Jean-Jacques
More informationThe PI includes important warnings and precautions. It states (in pertinent part):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE James L. Gaskill, PharmD Director Promotional Regulatory Affairs AstraZeneca
More informationGary Wieczorek, Associate Director, Regulatory Affairs Eisai Medical Research Inc. 300 Tice Blvd Woodcliff Lake, NJ 07677
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Gary Wieczorek, Associate Director, Regulatory Affairs 300 Tice
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE James Manuso, Ph.D. Chairman, President, and Chief Executive Officer
More informationTRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Sue Duvall, RN, MPA Associate Director, Drug Regulatory Affairs Pharmaceuticals
More informationWARNING LETTER. RE: NDA# COPAXONE (glatiramer acetate injection) solution for subcutaneous injection MA #762. Dear Mr.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Larry Downey Executive Vice President, US Branded Pharmaceuticals Teva Pharmaceuticals USA
More informationWARNING LETTER. The Indications and Usage section of the approved product labeling (PI) for Prograf states:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Hideo Fukumoto CEO Three Parkway North Deerfield, IL 60015-2548 RE:
More informationAccording to its FDA-approved product labeling (PI), Isovue is indicated for the following (in pertinent part):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Melanie Benson Director, US Regulatory Affairs 107 College Road
More informationDuragesic has the potential for abuse. The Drug Abuse and Dependence section of the PI states, in pertinent part:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Ajit Shetty, M.D. CEO Janssen Pharmaceutics, Inc. 1125 Trenton-Harbourton
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Nancy Konnerth Associate Director, Advertising and Labeling Drug Regulatory
More informationWARNING LETTER. The Indications and Usage section of the FDA-approved product labeling (PI) states (emphasis original):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED VIA FACSIMILE Cary R. Rayment President and Chief Executive Officer 6201 South Freeway
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Cary Rayment President and Chief Executive Officer Alcon, Inc. C/O
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Ajit Shetty, M.D. CEO Janssen Pharmaceutica, Inc. 1125 Trenton-Harbourton
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Stacy Holdsworth, PharmD Manager U.S. Regulatory Affairs Lilly Technology
More informationCENTER FOR DRUG EVALUATION AND RESEARCH. APPLICATION NUMBER: Orig1s000 APPROVAL LETTER
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202107Orig1s000 APPROVAL LETTER DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 202107 NDA APPROVAL
More informationE-ALERT Food & Drug SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH April 28, 2010
E-ALERT Food & Drug April 28, 2010 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH 2010 This e-alert is part of a monthly series of e-alerts summarizing publicly-available FDA enforcement
More informationWARNING LETTER. MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration TRANSMITTED BY FACSIMILE Steven Hanley President Imaging Division Mallinckrodt Inc. 675 McDonnell Boulevard P.O.
More informationWARNING LETTER. (F)or the prevention of pregnancy in women who elect to use an oral
~t-t\ Si-Vf('i.s '&, 5~ (: ~EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Reinhard Franzen President & Chief Executive
More informationDrug Review Rozerem (ramelteon)
Drug Review Rozerem (ramelteon) Introduction 1 Ramelteon is a melatonin receptor agonist with affinity for MT 1 and MT 2 and selectivity over the MT 3 receptor. The activity at the MT 1 and MT 2 receptors
More informationNDA NDA APPROVAL
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022200 NDA APPROVAL Amylin Pharmaceuticals, Inc. Orville Kolterman, M.D. Sr. Vice President, Research & Development
More informationWARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE David E.I. Pyott President and Chief Executive Officer PO Box 19534
More informationTeva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs 425 Privet Road Horsham, PA 19044
DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 090783 Food and Drug Administration Silver Spring, MD 20993 Teva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs
More informationIn May 2013, FDA s Office of Prescription Drug Promotion (OPDP) posted the following enforcement letters on FDA s website 1 :
E-ALERT Food & Drug June 27, 2013 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MAY 2013 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement
More informationRe: Docket No. FDA D Presenting Risk Information in Prescription Drug and Medical Device Promotion
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org August 25, 2009 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville,
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TEVA Pharmaceuticals LTD Attention: J. Michael Nicholas, Ph.D. Senior Director, U. S. Regulatory
More informationA Pharmacist s Guide to Intermezzo
A Pharmacist s Guide to Intermezzo Intermezzo (zolpidem tartrate) is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to
More informationWeb Meeting Sep 20, Presented by: Kimberly Belsky, DIA AdPromo WG Chair DIA, Inc. All Rights Reserved.
OPDP Warning Letter Posted Sep 2017 FDA Draft Guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling Q&A s (Issued January 2017) Web Meeting Sep 20, 2017 Presented by:
More informationThe Medical Letter. on Drugs and Therapeutics. Usual Adult Hypnotic Dose 1,2 Some Adverse Effects Comments Cost 3
The Medical Letter publications are protected by US and international copyright laws. Forwarding, copying or any other distribution of this material is strictly prohibited. For further information call:
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Non-Benzodiazepine Insomnia Medications Reference Number: CP.CPA.265 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Non-Benzodiazepine Insomnia Reference Number: CP.PMA_10.11.23 Effective Date: 07.16 Last Review Date: 04.18 Line of Business: Medicaid- Arizona (AHCS, CIC) Revision Log See Important Reminder
More informationOpiate Freedom Center 1/11/18
Opiate Freedom Center 1/11/18 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH FEDERAL TRADE COMMISSION AND HUMAN SERVICES BUREAU OF CONSUMER FOOD AND DRUG ADMINISTRATION PROTECTION SILVER SPRING, MD 20993
More informationNovartis Oncology 4/21/10
Home > Inspections, Compliance, Enforcement, and Criminal Investigations > Enforcement Actions > Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Novartis Oncology 4/21/10
More informationCassandra E. Curtis, M.D. 1/27/17
Cassandra E. Curtis, M.D. 1/27/17 CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER JAN 27, 2017 10903 New Hampshire Avenue Silver Spring, MD 20993 Cassandra E. Curtis, M.D. 45-01-02 4880 Century
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Non-Benzodiazepine Insomnia Medications Reference Number: CP.HNMC.265 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder
More informationRegulation of the Promotion of Prescription Drugs
Regulation of the Promotion of Prescription Drugs Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration August 23, 2006 Goal and Objectives
More informationE-ALERT Food & Drug SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES FEBRUARY April 5, 2010
E-ALERT Food & Drug April 5, 2010 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES FEBRUARY 2010 This e-alert is part of a monthly series of e-alerts summarizing publicly-available FDA enforcement
More informationNDA MF REMS ASSESSMENT ACKNOWLEDGMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 REMS ASSESSMENT ACKNOWLEDGMENT Insys Development Co. c/o Insys Therapeutics, Inc. 1333 South Spectrum Blvd.,
More informationAddiction, Pain, & Public Health website -
Addiction, Pain, & Public Health website - www.doctordeluca.com/ Dispensing of Controlled Substances for the Treatment of Pain -- Drug Enforcement Administration (DEA), Department of Justice; ACTION: Interim
More informationBLA /S-048, S-049, S-050, S-051, S-052, S-061, S-062, S-064, S-065, and S-066 SUPPLEMENT APPROVAL
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 BLA 125554/S-048, S-049, S-050, S-051, S-052, S-061, S-062, S-064, S-065, and S-066 SUPPLEMENT APPROVAL Bristol-Myers
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Stanislaw R Burzynski, MD 12/3/13
More informationInsomnia Agents (Sherwood Employer Group)
Insomnia Agents (Sherwood Employer Group) BCBSKS will review Prior Authorization requests Prior Authorization Form: https://www.bcbsks.com/customerservice/forms/pdf/priorauth-6058ks-st-ippi.pdf Link to
More informationConsistent with Labeling Final Guidance: Implications for Devices
Consistent with Labeling Final Guidance: Implications for Devices Vernessa Pollard, Partner, McDermott Will & Emery Cassie Scherer, Principal Legal Counsel, Medtronic Jeffrey Shapiro, Director, Hyman,
More informationE-ALERT Food & Drug April 30, 2012
E-ALERT Food & Drug April 30, 2012 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Burzynski Research Institute
More informationGuidance on Generating the Three Base Fair Balance Levels (HCP advertising)
Guidance on Generating the Three Base Fair Balance Levels (HCP advertising) June 2013 Decreased Comprehensiveness Preamble: In alignment with section 9.1 of the Food and Drugs Act, the PAAB code sections
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Apini$r$iy -tq 5-f
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Apini$r$iy -tq 5-f J Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145 Ref: 2004-DAL-WL-03 WARNING LETTER CERTIFIED MAIL RETURN
More informationMedical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Draft Guidance for Industry
Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Draft Guidance for Industry Elizabeth Pepinsky Health Science Policy Analyst Office of Prescription
More informationOPDP Update on Oversight of Prescription Drug Promotion
OPDP Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration September 26, 2017 Goal and Objectives Goal To protect
More informationRE: Permits under the Arizona Pharmacy Act should not be required for dietary supplements
Board Members Arizona State Board of Pharmacy 1616 W. Adams St., Suite 120 Phoenix, AZ 85007 c/o Kam Gandhi, PharmD Executive Director Arizona State Board of Pharmacy Via email: kgandhi@azpharmacy.gov
More informationFood & Drug SUMMARY OF DDMAC AND APLB ENFORCEMENT CORRESPONDENCE JULY 2009
Food & Drug August 31, 2009 SUMMARY OF DDMAC AND APLB ENFORCEMENT CORRESPONDENCE JULY 2009 In July 2009, FDA s Division of Drug Marketing, Advertising, and Communications (DDMAC) posted two warning letters
More informationSHIRE v FERRING. Promotion of Pentasa CASE AUTH/2299/2/10
CASE AUTH/2299/2/10 SHIRE v FERRING Promotion of Pentasa Shire complained about the promotion of Pentasa (mesalazine) by Ferring. The items at issue were a 'power of five' booklet, an A4 sheet and an advertisement
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations V-SAB Medical Labs,
More information8.6 Chronic Obstructive Pulmonary Disease 8.7 Sleep Apnea 1 INDICATIONS AND USAGE
Page 1 of 18 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM
More informationCITIZENS PETITION TO FOOD AND DRUG ADMINISTRATION. Division of Dockets Management Food and Drug Administration Room Fishers Lane
CITIZENS PETITION TO FOOD AND DRUG ADMINISTRATION Division of Dockets Management Food and Drug Administration Room 1061 5630 Fishers Lane Rockville, MD 20852 ) ALLIANCE FOR NATURAL HEALTH USA ) 1350 Connecticut
More informationSMOKING CESSATION IS HARD
POWER TO BREAK THE HOLD OF NICOTINE ADDICTION 1 SMOKING CESSATION IS HARD Most smokers try to quit 5-7 times before they are successful. 2 Why is it so hard to quit? Typical withdrawal symptoms from stopping
More informationClass II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA Document issued on: November 12, 2002 This document supersedes the
More informationMobile Medical Devices Final Project Assignment Submittal of the MMDA 510(k)
Mobile Medical Devices Final Project Assignment Submittal of the MMDA 510(k) [Base upon http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/prem arketnotification510k/ucm142651.htm
More informationNestle Infant Nutrition 10/31/14
U.S. Food and Drug Administration Protecting and Promoting Your Health Nestle Infant Nutrition 10/31/14 OCT 31, 2014 Department of Health and Human Services Public Health Service Food and Drug Administration
More informationE-ALERT Food & Drug 2011 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY OPDP I. ENFORCEMENT ACTIVITY
E-ALERT Food & Drug February 7, 2012 2011 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY This client alert reviews the warning and untitled letters issued in 2011 by the Office of Prescription
More informationClinical Policy: Buprenorphine-Naloxone (Suboxone, Bunavail, Zubsolv) Reference Number: CP.PMN.XX. Line of Business: Medicaid
Clinical Policy: (Suboxone, Bunavail, Zubsolv) Reference Number: CP.PMN.XX Effective Date: 09/17 Last Review Date: 08/17 Line of Business: Medicaid See Important Reminder at the end of this policy for
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home > Inspections, Compliance, Enforcement, and Criminal Investigations > Enforcement Actions > Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Chawla, Sant P., M.D.
More informationTheoriginalhcgdrops.com 11/28/11
Theoriginalhcgdrops.com 11/28/11 UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
More informationGuidance on Base Fair Balance Level Selection and Placement (HCP Advertising)
Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising) June 2013 Preamble: In alignment with section 9.1 of the Food and Drugs Act, the PAAB code sections 2.1, 2.4, and 3.5 require
More informationSUBSYS National Drug Code Directory
20482-016-15 SUBSYS The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated,
More informationClinical Policy: Modafinil (Provigil) Reference Number: CP.PMN.39. Line of Business: Medicaid
Clinical Policy: (Provigil) Reference Number: CP.PMN.39 Effective Date: 05/08 Last Review Date: 05/17 Line of Business: Medicaid Coding Implications Revision Log See Important Reminder at the end of this
More informationDOD PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL
DOD PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL I. UNIFORM FORMULARY REVIEW PROCESS Under 10 United States Code 1074g, as implemented
More informationE-ALERT Food & Drug 2013 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY OFFICE OF PRESCRIPTION DRUG PROMOTION (OPDP)
E-ALERT Food & Drug April 25, 2014 2013 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY This alert reviews the warning and untitled letters issued in 2013 by the Office of Prescription Drug
More informationPharmacy Medical Necessity Guidelines: Insomnia Treatments
Pharmacy Medical Necessity Guidelines: Effective: January 1, 2019 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit
More informationPATIENT QUESTIONNAIRE
PATIENT QUESTIONNAIRE Personal Information Date Name Date of Birth Age Height Weight Gender: Male / Female Address City State / Zip Home Phone Cell phone Work phone E-mail address Do you currently have
More informationRaritan Pharmaceuticals, Inc. 6/20/17
Raritan Pharmaceuticals, Inc. 6/20/17 U.S. Food & Drug Administration Division of Pharmaceutical Quality Operations I New Jersey District 10 Waterview Boulevard, 3rd Floor Parsippany, NJ 07054 June 20,
More informationHetlioz (tasimelteon)
Hetlioz (tasimelteon) Policy Number: 5.01.687 Last Review: 01/2019 Origination: 01/2019 Next Review: 01/2020 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Hetlioz
More informationyour submissions dated October 12, No.vember 9 and 1, and April 7,2008.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service (.,... t. ~J'O ~~ Food and Drug Administration """'~4~""RVIC'S' ''r Rockvile, MD 20857 STN: BL 125118/045 Bristól~Myers Squibb Company P.O. Box
More informationKETAMINE HYDROCHLORIDE National Drug Code Directory
42023-138-10 KETAMINE HYDROCHLORIDE The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured,
More informationJanuary 7, Dear Ms. Chung:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 January 7, 2015 Jeisys
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home > Inspections, Compliance, Enforcement, and Criminal Investigations > Enforcement Actions > Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Punjwani, Sohail S., M.D.
More informationEU Core Safety Profile
EU Core Safety Profile Active Substance: Triazolam Brand Names: HALCION, SOMESE Pharmaceutical form(s)/strength: Tablets RMS: Finland Date: 9 th Dec 2013 Supersedes: 24 th May 2010 4.3. Contraindications
More informationINTERNATIONAL STANDARD ON ASSURANCE ENGAGEMENTS 3000 ASSURANCE ENGAGEMENTS OTHER THAN AUDITS OR REVIEWS OF HISTORICAL FINANCIAL INFORMATION CONTENTS
INTERNATIONAL STANDARD ON ASSURANCE ENGAGEMENTS 3000 ASSURANCE ENGAGEMENTS OTHER THAN AUDITS OR REVIEWS OF HISTORICAL FINANCIAL INFORMATION (Effective for assurance reports dated on or after January 1,
More informationClinical Policy: Fluticasone/Salmeterol (Advair Diskus, Advair HFA) Reference Number: CP.PMN.31 Effective Date: 08/16 Last Review Date: 08/17
Clinical Policy: (Advair Diskus, Advair HFA) Reference Number: CP.PMN.31 Effective Date: 08/16 Last Review Date: 08/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this
More information