Generics and Manufacturing: What Prescribers Need to Know
|
|
- Rudolph Arnold
- 6 years ago
- Views:
Transcription
1 Generics and Manufacturing: What Prescribers Need to Know Michael B. Bottorff, Pharm.D., FCCP,FNLA,CLS Professor and Chair Department of Pharmacy Practice South College School of Pharmacy
2 Disclosures Speaker bureaus for Sanofi-Aventis, Boehringer-Ingelheim, Bristol- Myers Squibb, Pfizer, Amarin Consultant Abbott Labs I still write with pens having drug company names
3 Outline Define a generic drug Explore the US landscape of generic drug use Review the criteria for FDA approval of a generic drug Describe the FDA Orange Book and its AB designation for generic substitution Explore the complexities of the 1984 Hatch-Waxman Act and its impact on generic drug approvals
4
5 US Top 200 Drugs of Interest Simvastatin (5) Metformin (6) Atorvastatin (13) Warfarin (23) Clopidogrel (25) Lovastatin (37) Pravastatin (40) Rosuvastatin (46) Fenofibrate (63) Niacin (ER) (134) Gemfibrozil (141) Lisinopril (1) Levothyroxine (2) Hydrocodone (3) Omeprazole (4) Sigler drug cards 29 th edition
6 What is a Generic Drug? Per the FDA, generic drugs are: copies of brand-name drugs and are the same in terms of Dosage form Strength Route of administration Safety Quality Performance characteristics Intended use Furthermore, generic manufacturing, packaging and testing sites must pass the same standards as the originator drug Ranbaxy USA, a subsidiary of an Indian generic manufacturer was fined $500 million due to the distribution of adulterated cipro and gabapentin (Dept of Justice May 13, 2013) accessed 7/23/2013
7 Generic Drugs in the U.S. Nearly 8 in ten prescriptions are for generic drugs Generic drugs must be proven to be bioequivalent to brand name counterparts Average cost of a generic is 80-85% below the branded counterpart Approximately $5 billion saved each week due to generic drug use 57% of which are CNS and cardiovascular drugs Generic Drug Usage in the U.S., GPhA, September 2011, page 1
8 Origin of Generic Drugs 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) Incentivizing the development of new drugs Adding up to five years of patent protection for branded drugs due to the delay in FDA approval Facilitating the availability of less expensive drugs for the consumer Prohibits the FDA from requiring more than bioavailability studies for generic drug ANDAs Paragraph IV sets 180 day exclusivity to companies first-to-file a generic ANDA accessed 8/12/13
9 What is an ANDA Abbreviated New Drug Application (ANDA) Generic drug data submitted to the FDAs Center for Drug Evaluation and Research (CDER), Office of Generic Drugs Abbreviated since they do not contain pre-clinical and clinical data to establish safety and efficacy Must scientifically demonstrate bioequivalence Same rate and extent of absorption, therefore delivering the same amount of active ingredient over the same amount of time Guidance Documents for ANDAs Bioequivalence testing, statistical approaches, food-effect testing, etc. accessed 7/23/2013
10
11 NDA vs ANDA Reviews Original Drug NDA Chemistry Manufacturing Controls Labeling Testing Animal Studies Clinical Studies (including bioavailability) Generic Drug ANDA Chemistry Manufacturing Controls Labeling Testing Bioequivalence Studies (in vivo and possibly *in vitro) *Comparative dissolution testing may be allowed when there is an established in vitro/in vivo correlation per CDER handbook 2003
12 Pharmacokinetic / Pharmacodynamic Relationships MEC Drug Toxicity Drug Effect (Cp) Peak Effet (Cmax) Systemic Exposure (Area Under The Curve, AUC) Therapeutic Window MEC Drug Effect Onset of effect Time
13 2 x 2 CROSS-OVER DESIGN subjects R A N D O M I Z A T I O N sequence 1 sequence 2 period 1 period 2 R T W A S H O U T T R
14 FDA Standardized High-Fat Test Meal Two eggs fried in butter Two strips of bacon Two slices of toast with butter Four ounces of hash brown potatoes Eight ounces of whole milk Protein Carbohydrate 150 kcal 250 kcal Fat kcal
15 Calculating Area Under the Curve (AUC) Malinowski and Johnson, in Remingtons 2006
16 Bioavailability Parameters and BE Tmax Plasma Concentration Plasma Concentration Cmax Time (hr) Time (hr) Two products can have same Tmax or Cmax and not be bioequivalent
17 Bioequivalence Examples Malinowski and Johnson, in Remingtons 2006
18 Definitions Definitions in terms of the ratio of the two geometric means µ T /µ R, where µ T and µ R are the geometric means of the test and reference products, respectively Bioequivalence interval [80%, 125%] Bio-inequivalence regions (0, 80%) or (125%, ) µ T /µ R 0 Bio-inequivalence Region 80% 125% Bioequivalence Interval Bio-inequivalence Region Li et al, CDER
19 Evaluating Three PK Endpoints Three PK parameters (AUC t, AUC, C max ) used to assess bioequivalence. Bioequivalence of two drugs requires that all the three PK parameters should be equivalent in terms of the bioequivalence interval using ratios µ T /µ R. There are FDA guidelines for Log transformation of pharmacokinetic data Methods to evaluate sequence effects Methods to evaluate outlier data
20 Three PK Endpoints for Bioequivalence The statistical criteria used to demonstrate bioequivalence for the three PK parameters are to have all the 2-sided 90% CIs for the ratios to be within [80%, 125%]. D.J. Schuirmann: A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15: , 1987.
21 90% CONFIDENCE INTERVAL 90% CI 1.04 ( ) point estimate Based on the statistical power to detect a 20% difference in the ratio of geometric means and SE for BE parameters, it is difficult for a drug whose actual arithmetic mean differs by more than 10% to meet the requirements for approval (Henderson et al, S Med Journal 2001)
22 Statistical analysis BE criteria -Two one-sided tests procedure Test (T) is not significantly less than reference Reference (R) is not significantly less than test Significant difference is 20% (α = 0.05 significance level) T/R = 80/100 = 80%, or 100/80 =125%
23 Assessment of BE Based on Point Estimate and 90% CI Demonstrates BE Fails to demonstrate BE Fails to demonstrate BE Demonstrates BIE Demonstrates BIE 80% 125% T/R (%)
24 Example: Generic Drug X Parameter Test A Reference B Ratio 90% CI AUC 0-t (ng*hr/ml) AUC 0- (ng*hr/ml) Cmax (ng/ml) Log transformed data with serum nicotinuric acid, N=45
25 Position of FDA on Narrow Therapeutic Index Drugs (NTI) To date, there are no documented examples of failure of a generic drug due to a bioequivalence issue (warfarin, digoxin) Products determined bioequivalent should not require any additional clinical testing or monitoring Am J Health Syst Pharm 1997
26 Approved Drug Products with Therapeutic Equivalent Evaluations The Orange Book Due to numerous states requesting the FDA for a list of equivalent drug products, the FDA announced in 1978 the creation of the Orange Book The Orange Book is so named since it was finished in October 1980 Orange book is available at the FDA website and updated every few weeks Lists all approved drug products with their therapeutic equivalent codes and relevant patents accessed 7/23/2013
27 Therapeutic Equivalence Evaluation Codes A Codes drug products deemed therapeutically equivalent to other products AA products in conventional dosage forms not considered bioequivalence problems (eg., ophthalmic solutions) ABproducts meeting bioequivalence requirements There are other codes for aerosolization, injectable oil/aqueous solutions, topical products B Codes drug products that the FDA does not consider to be therapeutically equivalent to other pharmaceutically equivalent products BC extended release capsules, tablets, injectables BN products in nebulizer drug delivery systems Accessed August 12, 2013
28 AB Rated Generic Drugs for Dyslipidemia on the US Market Lovastatin (Mevacor) Actavis, Apotex, Carlsbad, Lupin, Mutual, Mylan, Sandoz, Teva Pravastatin (Pravachol) Apotex, Glenmark, Lupin, Mylan, Teva, Watson, Zydus and Dr. Reddys Labs Simvastatin (Zocor) Accord, Aurobindo, Blue Caribe, Dr. Reddys Labs, Ivax, Lupin, Micro, Mylan, Prosan, Ranbaxy, Watson, Zydus Atorvastatin (Lipitor) Apotex, Dr. Reddys Labs, KudCo, Mylan, Ranbaxy, Sandoz Fluvastatin (Lescol) Mylan, Teva Fenofibrate and fenofibric acid (Tricor, Trilipix) Anchen (FA July 18, 2013), Mylan, Apotex, Dr. Reddy, Cypher, Impax, Lupin, Teva, Ranbaxy, etc.
29 Patent Issues If an ANDA is filed for a generic drug prior to the end of the patent life, the sponsor of the ANDA must prove that the patents at issue are either Invalid Not infringed upon Once the ANDA is filed, the innovator company has 45 days to file suit and the ANDA approval is on hold for 30 months Issues: NDA patent holders file with the FDA but the FDA does not review patents, only lists them Numerous lawsuits result from the separation of the patent approval process and the drug approval process Borecki CASRIP 2001
30 Patents, Challenges, Antitrust Issues Patents on NDA approved drugs are awarded for a period of 20 years Prospective generic companies have submitted ANDAs prior to this period in hopes of challenging the validity of innovator drug patents Many of these patent challenges are settled out of court and raise antitrust issues Apotex introduced a generic clopidogrel ($3.2 billion 2005) distributed in the US for three weeks in 2006 before a district judge halted further sales Several settlement attempts were rejected and the Department of Justice opened an investigation BMS plead guilty and fined $1 million for misrepresenting the terms of the settlement to the Antitrust Division of the Justice Department Apotex pays $442 million in damages to BMS/Sanofi when patent is upheld Wall Street Journal Feb 8, 2012
31 Proposed Pathways of Niacin Metabolism Biomed Chromatog 2011; 25: Niaspan Patents Safety of once a day administration of an extended release form Pharmacokinetic parameters such as Cmax and AUC Urinary recovery of Pathway I and II metabolites Co-aministration with a statin, ASA
32 Case History: Niacin (Niaspan) Niaspan approved by the FDA in 1997 Two patents expire in 2013 and 2017 US patent number 6,080,428 and 6,129,930 Barr (now Teva) filed an ANDA in 2001 and Kos (now Abbott) sued, reaching an agreement in 2005 Barr received $5 million payment plus a quarterly amount and retained the 180 day exclusivity period Barr scheduled to launch generic versions of Niaspan and Advicor in Sept, 2013, 3 months before the first patent expiration date and 4 years before the expiration of the 2017 patent A New York hotel workers union filed an antitrust class action suit in May 2013 for so called reverse payments Other Niaspan settlements include Lupin, Sun, Watson, Mylan and Sandoz Hemphill, Sierra May 20,
33 Recent Rulings of Interest Supreme Court Ruling in FTC vs Actavis Ruling on reverse payment agreements (pay for delay) Orders district court to evaluate each case on the rule of reason, a standard for determing violations of antitrust law Reverse payment agreements therefore are not immune from antitrust litigation per se and must be evaluated case-by-case NEJM August 2013
34 Prescription Omega-3 Fish Oil (lovaza) In April 2009, Pronova (manufacturer, GlaxoSmithKline marketer) filed patent infringement suits against Par and Teva for generic versions of Lovaza September 12, 2013 a US appeals court ruled the patents in question invalid, reversing a lower court decision upholding the patents May open the door for early entry of lovaza generics unless appealed to US Supreme Court Reuters September 12, 2013
35 Summary and Conclusions Generic drugs are an important part of prescribing in the US and leads to more affordable medications The bioequivalence and statistical criteria to approve most generic drugs assures minimal difference from the original branded drug Attempts to delay the early introduction of generics puts major pharmaceutical companies at risk of violating antitrust laws
Information for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs CADUET (amlodipine besylate/atorvastatin calcium) tablets This list does not imply that the products on this chart are interchangeable or have
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs LIPITOR (atorvastatin calcium) tablets This list does not imply that the products on this chart are interchangeable or have the same efficacy or
More informationClinical Endpoint Bioequivalence Study Review in ANDA Submissions. Ying Fan, Ph.D.
Clinical Endpoint Bioequivalence Study Review in ANDA Submissions Ying Fan, Ph.D. 1 Disclaimer This presentation constitutes an informal communication that represents the best judgment of the speaker at
More informationORANGE BOOK ORANGE BOOK
1 INTRODUCTION: DEFINITION: The official title of the book is Approved Drug Products with Therapeutic Equivalence Evaluations. Orange book is a publication by the Food and Drug Administration which contains
More informationUS pharmaceutical market: trends, issues, forecast. Doug Long Vice President Industry Relations IMS Health
US pharmaceutical market: trends, issues, forecast Doug Long Vice President Industry Relations IMS Health 2006 Strategic management review The World Pharmaceutical Market All reproduction rights, quotations,
More informationGeneric Medicines in Australia. Andrew McLachlan
Generic Medicines in Australia Andrew McLachlan andrewm@pharm.usyd.edu.au The aim of this presentation Overview of medicines policy and regulation in Australia Generic medicines in the Australia market
More informationSimvastatin 40 mg equivalent
Simvastatin 40 mg equivalent medications equivalent to Simvastatin is available on the Drugs.com website. Simvastatin (Zocor ): 10 mg : Equivalent Dosages - 3: Atorvastatin (Lipitor. 40 mg : Equivalent
More informationJanuary 2005 Legal Aspects of Pharmacy: Using the Orange Book for Bioequivalence Evaluations H03
W-F Professional Associates, Inc. 400 Lake Cook Rd., Suite 207 Deerfield, IL 60015 847-945-8050 January 2005 Legal Aspects of Pharmacy: Using the Orange Book for Bioequivalence Evaluations 707-000-05-001-H03
More informationTo Substitute or Not to Substitute: That Is the Question
To Substitute or Not to Substitute: That Is the Question Published Online: Monday, March 14th, 2011 Tina Zerilli, PharmD; Andy He, PharmD Candidate 2011; Joseph P. Nathan, MS, PharmD; and Sara Grossman,
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 informationA study on Metformin (1, 1-Dimethylbiguanidemonohydrochloride) reported adverse events as observed in Eudravigilance database
A study on Metformin (1, 1-Dimethylbiguanidemonohydrochloride) reported adverse events as observed in Eudravigilance database Contract Research Organization / Terzetto Pharma Metrics NIVETHA CHELLAPATHY
More informationReviews/Evaluations. Generic Substitution. Overview. Generic Quality. Bioequivalence
Reviews/Evaluations Generic Substitution Overview The 1984 Drug Competition and Patent Term Restoration Act, also called the Hatch-Waxman Act, expedited approval of generics. Generic use climbed 19% that
More informationBrand and Generic Drugs. Educational Objectives. Absorption
Peter J. Rice, PharmD, PhD Associate Professor of Pharmacology East Tennessee State University Educational Objectives Pharmacokinetic Processes Distribution Metabolism Excretion Similarities Active ingredient(s)
More informationRESULTS AND DISCUSSION
RESULTS AND DISCUSSION 203 4.1 General Introduction: The researcher has collected both the primary and secondary data. The primary data is collected by direct interaction by using formal questionnaire
More informationCholesterol. Medicines To Help You
Medicines To Help You Cholesterol Use this guide to help you talk to your doctor, pharmacist, or nurse about your cholesterol medicines. The guide lists all of the FDA-approved products now available to
More informationCase 1:14-cv LPS Document 195 Filed 01/05/16 Page 1 of 5 PageID #: 6023
Case 1:14-cv-00121-LPS Document 195 Filed 01/05/16 Page 1 of 5 PageID #: 6023 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FOREST LABO RA TORIES, INC., FOREST LABO RA TORIES HOLDINGS,
More informationPrescription Drugs. Medicare & Medicaid Briefings National Health Policy Forum February 22, Jim Hahn Congressional Research Service
Prescription Drugs Medicare & Medicaid Briefings National Health Policy Forum February 22, 2007 Jim Hahn Congressional Research Service Global and US. Prescription Drug Sales, 1998-2005 $700 $600 559 602
More informationDiseases & Conditions
http://my.clevelandclinic.org Diseases & Conditions About Cholesterol-Lowering Drugs Some people have a genetic predisposition to high blood cholesterol levels. These people may need drug therapy in addition
More informationInformation for Vermont Prescribers of Prescription Drugs Tradjenta (linagliptin) and Jentadueto (linagliptin+metformin) Tablets
Information for Vermont Prescribers of Prescription Drugs Tradjenta (linagliptin) and Jentadueto (linagliptin+metformin) Tablets This list does not imply that the products on this chart are interchangeable
More informationFDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES
FDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES 1 SCOPE In pursuance of section 47 of the Food and Drugs Law 1992, P.N.D.C.L 305B, as amended by Act 523, 1996, these
More informationCardiovascular Drugs and Therapies HMG CoA a REDUCTASE INHIBITORS (available in Canada)
Trade Name Dosage Forms 10 mg, 20 mg, 40 mg, 80 mg tablets Dosing Range 10-80 mg once daily 2 Dosing Based on Desired LDL Reduction 1,2,3 HMG CoA a REDUCTASE INHIBITORS (available in Canada) LIPITOR, generics
More informationUnigel TM Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations
Unigel TM Case Study: Extending Soft Gelatin Capsule Benefits to Novel Fixed Dose Combinations Diego Monterroza, H. M. Sc, Corporate Manager, R&D Procaps S.A. Stand # 30A46 OUTLINE Fixed Dose Combinations
More informationReceived: ; Revised; Accepted: A REVIEW ON BIOAVAILABILITY AND BIOEQUIVALENCE STUDY Shashi Kant*, Bharat Parashar
International Journal of Institutional Pharmacy and Life Sciences 2(5): September-October 2012 INTERNATIONAL JOURNAL OF INSTITUTIONAL PHARMACY AND LIFE SCIENCES Pharmaceutical Sciences Review Article!!!
More informationPravastatin conversion to atorvastatin
P ford residence southampton, ny Pravastatin conversion to atorvastatin Pravastatin official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology
More informationGeneric Drug Approval Process
1 Generic Drug Approval Process Sharon Ricciardo Katherine P. Weld. M.S., Ph.D. AAVPT Veterinary Drug Regulatory Life Cycle Course March 2, 2011 Overview Background Approval Process Bioequivalence Special
More informationInterchangeable Drug Products - Additional Criteria
Interchangeable Drug Products - Additional Criteria Principle: Decisions respecting interchangeability and drug lists remain in the domain of the institution responsible for the costs of the product which
More informationFree Trial Future Generics Database
API Atazanavir Structure O 2 C N H O H N OH N NH O N H N CO2 Brand REYATAZ (BMS : World) Indication Antiviral Originator Ciba-Geigy (Novartis) Developer / Licensee BMS Comments Atazanavir is an azapeptide
More informationBRIC DIABETES DRUGS MARKET
BRIC DIABETES DRUGS MARKET R e p o r t D e s c r i p t i o n T a b l e o f C o n t e n t s L i s t o f T a b l e s S a m p l e T a b l e s R e l a t e d R e p o r t s A b o u t M a r k e t s a n d M a
More informationHave you been paying for your prescription drugs? Stop!
Dear Valued Medtipster Member: Have you been paying for your prescription drugs? Stop! Free prescription drugs are NOW just a Medtipster ID card away. Follow the steps below to obtain thousands of generic
More informationSTATIN UTILIZATION MANAGEMENT CRITERIA
STATIN UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: HMG Co-A Reductase Inhibitors & Combinations Agents which require prior review: Advicor (niacin extended-release/lovastatin) Crestor (rosuvastatin)(5mg,10mg,
More informationSOLVAY GROUP London Morning Meeting. June 26, 2009
SOLVAY GROUP London Morning Meeting June 2, 9 1 Our fenofibrate franchise Klaus Kirchgassler, MD Sr VP Solvay Pharmaceuticals 2 Summary of lipid lowering market performance in Value Growth vs. previous
More informationGeneric Inhaled Medications
Generic Inhaled Medications Financial Interest Disclosure (over the past 24 months) Irvin Mayers Company Speaker Advisory Research Medimmune Novartis GSK Boehringer Ingelheim CADTH Health Canada Financial
More informationUnderstanding the Value of Generic Drugs
Understanding the Value of Generic Drugs Generic drugs can help you get the most out of your health care budget. 05.02.306.1 (8/05) Many people believe that when something costs more, it must be of higher
More informationPharmacy benefit guide
FlexRx SM 5-Tier Pharmacy benefit guide 1 Welcome to FlexRx The NHP FlexRx SM program is built for choice, savings, and convenience with benefits including: Low-cost drug tier for many common medications
More informationAtorvastatin 40 Mg Cost
Atorvastatin 40 Mg Cost lipitor 20 mg atorvastatin Free Coupons For Benicar Custa Xenical Manipulado atorvastatin 20 mg tablet price what is atorvastatin calcium tablets ip atorvastatin 40 mg tabletta
More informationThe science behind generic drugs
The science behind generic drugs Are generics manufactured to the same high quality standards? Are generics equivalent to the pioneer? Do pioneer drugs go through more testing? Should I feel confident
More informationVolume 9; Number 3 March 2015 PRESCRIBING AND DISPENSING PREGABALIN FOR NEUROPATHIC PAIN
Arden and Greater East Midlands Commissioning Support Unit in association with Lincolnshire Clinical Commissioning Groups, Lincolnshire Community Health Services, United Lincolnshire Hospitals Trust and
More informationCardioPharma. CP-101 CardiaPill The Game Changer in Treating CVD
1 CardioPharma CP-101 CardiaPill The Game Changer in Treating CVD 2 Forward looking statements This presentation includes forward-looking statements including statements regarding the timing and outcome
More informationGuide to Interchangeable Medicines
Guide to Interchangeable Medicines AUT-G0115-6 01 JUNE 2018 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS 1 BACKGROUND 3 1.1
More informationDoctor discussion guide:
Doctor discussion guide: MAnaging Cholesterol Bring this printout to your next doctor s appointment. It will help you and your doctor work together to set goals for treatment, evaluate the success of your
More informationPATIENT INFORMATION. Medicine To Treat: C ardiac Diseases. Lipid-Lowering Medicines. Statins Fibrates Fat Binding Agents Nicotinic Acid Group
PATIENT INFORMATION Medicine To Treat: C ardiac Diseases Lipid-Lowering Medicines Statins Fibrates Fat Binding Agents Nicotinic Acid Group ABOUT YOUR MEDICINE Your doctor has just prescribed for you: Medicine
More informationGeneric Drugs: What does equal really mean? Dr. Peter J. Lin Director Primary Care Initiatives Canadian Heart Research Centre
Generic Drugs: What does equal really mean? Dr. Peter J. Lin Director Primary Care Initiatives Canadian Heart Research Centre Copyright 2017 by Sea Courses Inc. All rights reserved. No part of this document
More informationDoctor discussion guide:
Bring this printout to your next doctor s appointment. It will help you and your doctor work together to set goals for treatment, evaluate the success of your treatment, and reduce your risk of side effects.
More informationCHOLESTEROL REDUCING MEDICATIONS. Five Main Categories. 1. Statins 2. Fibrates 3. Resins 4. Niacin 5. Cholesterol absorption inhibitor
Page 1 of 5 PHA-GEN-002-2004 CHOLESTEROL REDUCING MEDICATIONS Five Main Categories 1. Statins 2. Fibrates 3. Resins 4. Niacin 5. Cholesterol absorption inhibitor Statins Also called HMG-CoA reductase inhibitors
More informationHigh ( 50%) Restrictions mg 20-40mg PA; TS ⱡ 15 ⱡ
MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Cholesterol P&T DATE: 5/9/2017 THERAPEUTIC CLASS: Cardiovascular REVIEW HISTORY: 5/16, 5/15, 2/14, 5/12, LOB AFFECTED: Medi-Cal
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs ARTHROTEC (diclofenac sodium/misoprostol) tablets This list does not imply that the products on this chart are interchangeable or have the same
More informationSpring Understanding the potential of generic substitution
Spring 2014 Understanding the potential of generic substitution Understanding the potential of generic substitution Generic pricing reforms and the availability of generics for blockbuster drugs coming
More informationSCIENTIFIC DISCUSSION. Antimycobacterial (J04AC01).
SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): International Nonproprietary Name: Pharmaco-therapeutic
More informationREGULATORY UPDATES: APPROVAL, DENIALS AND AGREEMENTS REGULATORY UPDATES: APPROVAL, (CONTINUED)... 38
CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED
More informationIN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION MEMORANDUM OPINION AND ORDER
Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al Doc. 251 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION ALLERGAN, INC., Plaintiff, v. TEVA PHARMACEUTICALS
More information1.* Dosage. A. Adults
3-Hydroxy-3-Methylglutaryl Coenzyme A (HMG-CoA) Reductase Inhibitors [Developed, November 1994; Revised, October 1996; September 1997; September 1998; October 1999; November 1999; August 2000; September
More informationI. BACKGROUND. Docket No. FDA-2009-P Dear Dr. Aikman:
DEPARTMENT OF HEALTH &. HUMAN SERVICES Food and Drug Administration Rockville MD 20857 Mark S. Aikman, Pharm.D. Vice President, Regulatory Affairs and Quality Assurance Osmotica Pharmaceutical Corp. 1205
More informationVirtually every state in the United States REVIEW GENERIC AEDS: CURRENT STANDARDS AND RECOMMENDATIONS. Michel J. Berg, MD * ABSTRACT
GENERIC AEDS: CURRENT STANDARDS AND RECOMMENDATIONS Michel J. Berg, MD * ABSTRACT Among strong and conflicting viewpoints on the substitution of brand-name antiepileptic drugs (AEDs) with their generic
More informationCurrent Challenges and Opportunities in Demonstrating Bioequivalence
Current Challenges and Opportunities in Demonstrating Bioequivalence Gur Jai Pal Singh, Ph.D. Watson Laboratories, Inc. Corona, California, USA Demonstrating Bioequivalence of Locally Acting Orally Inhaled
More informationBruce Wilkinson. Formulary & Benefit (F&B) Copay Summary Recommendation
Bruce Wilkinson Formulary & Benefit (F&B) Copay Summary Recommendation F&B Summary Copay Usage Goal: Use the Summary Copay files in a consistent manner with other F&B file types, specifically formulary
More informationPBS Growth. The changing composition of the PBS. PBS Top 10 drugs in transition. Shifting sands for industry as generic volume soars
PBS Growth The changing composition of the PBS PBS Top 10 drugs in transition Shifting sands for industry as generic volume soars The under co-payment market PBS Update 2014-15 Growth in PBS spending was
More informationInternational Journal of Research in Pharmacy and Science
Review article Available online www.ijrpsonline.com ISSN: 2249 3522 International Journal of Research in Pharmacy and Science Comparison of Regulatory Aspects for the Conduct of Bioavailability and Bioequivalence
More informationGuidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance
More informationRx Watchdog Report Trends in Manufacturer Prices of Generic Prescription Drugs Used by Medicare Beneficiaries 2003 to 2007
Rx Watchdog Report Trends in Manufacturer Prices of Generic Prescription Drugs Used by Medicare Beneficiaries 2003 to 2007 by David J. Gross AARP Outreach & Service Stephen W. Schondelmeyer PRIME Institute,
More informationInformation for Vermont Prescribers of Prescription Drugs. Lunesta (eszopiclone tablets)
Information for Vermont Prescribers of Prescription Drugs Lunesta (eszopiclone tablets) This list does not imply that the products on this chart are interchangeable or have the same efficacy or safety.
More informationInformation for Vermont Prescribers of Prescription Drugs Long Form
Information for Vermont Prescribers of Prescription Drugs Long Form Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) Capsules The prices listed below are Average Wholesale
More informationBiopharmaceutics of Non-Orally Administrated Drugs
Biopharmaceutics of Non-Orally Administrated Drugs Robert Lionberger, Ph.D. Deputy Director for Science (acting) Office of Generic Drugs, FDA November 21, 2013 AAPS Webinar Opinions expressed in this presentation
More information4/26/2013. Libia Lugo Drug Specialist San Juan District Office Investigations Branch
Libia Lugo Drug Specialist San Juan District Office Investigations Branch The Food and Drug Administration (FDA) responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico,
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs ARTHROTEC (diclofenac sodium/misoprostol) tablets This list does not imply that the products on this chart are interchangeable or have the same
More informationA world leading addiction treatment company with enormous future potential. Jefferies Conference, London 18 th November 2015
A world leading addiction treatment company with enormous future potential Jefferies Conference, London 18 th November 2015 Forward looking statements This presentation contains certain statements that
More informationTools for Targeting High Risk Patients in Your Practice. Statement of Disclosure
Tools for Targeting High Risk Patients in Your Practice Joseph Vande Griend, PharmD, BCPS, CGP Assistant Professor, University of Colorado Departments of Clinical Pharmacy and Family Medicine Skaggs School
More informationNon-Statin Lipid-Lowering Agents M Holler - Last updated: 10/2016
Drug/Class Cholestyramine (Questran) Bile acid sequestrant Generic? Lipid Effects Y/N (monotherapy) Y LDL : 9% (4 g to 8 ; 21% (16 g to 20 ; 23% to 28% (>20 HDL : 4% to 8% (16 to 24 TG : 11% to 28% (4
More informationFORWARD LOOKING STATEMENTS
FORWARD LOOKING STATEMENTS Except for historical facts, the statements in this presentation of supplemental information, as well as oral statements or other written statements made or to be made by Lannett
More informationDRAFT GUIDANCE DOCUMENT Comparative Bioavailability Standards: Formulations Used for Systemic Effects
1 2 3 DRAFT GUIDANCE DOCUMENT Comparative Bioavailability Standards: Formulations Used for Systemic Effects 4 This guidance document is being distributed for comment purposes only. 5 6 Published by authority
More informationSoma)con PHARMACEUTICALS
Soma)con PHARMACEUTICALS 5357 11 OCT 20 A10 AO Division of Dockets Management (HFA-305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
More informationANCHOR Study Results Overview
TM ANCHOR Study Results Overview April 18, 2010 Nasdaq: AMRN www.amarincorp.com 1 Forward Looking Statement This presentation contains forward looking statements, including those relating to the Company
More informationIMPACT OF PHARMACY REGULATION AND PAYMENT ON GENERIC DRUG USE IN THE MEDICAID PROGRAMS: 1991 TO 2008
IMPACT OF PHARMACY REGULATION AND PAYMENT ON GENERIC DRUG USE IN THE MEDICAID PROGRAMS: 1991 TO 2008 A DISSERTATION SUBMITTED TO THE FACULTY OF THE GRADUATE SCHOOL UNIVERSITY OF MINNESOTA BY DANIEL A.
More informationGAO BRAND-NAME PRESCRIPTION DRUG PRICING
GAO United States Government Accountability Office Report to Congressional Requesters December 2009 BRAND-NAME PRESCRIPTION DRUG PRICING Lack of Therapeutically Equivalent Drugs and Limited Competition
More informationBIOEQUIVALENCE AND THERAPEUTIC EQUIVALENCE. Soula Kyriacos, B.Pharm, PhD Head R&D, Pharmaline November 2016
BIOEQUIVALENCE AND THERAPEUTIC EQUIVALENCE Soula Kyriacos, B.Pharm, PhD Head R&D, Pharmaline November 2016 Introduction Early 1970 s FDA regulations for submission of BA data 1984 US Congress passed the
More informationCase 1:16-cv UNA Document 1 Filed 04/22/16 Page 1 of 10 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
Case 1:16-cv-00289-UNA Document 1 Filed 04/22/16 Page 1 of 10 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NOVARTIS AG, NOVARTIS PHARMACEUTICALS CORPORATION, MITSUBISHI
More informationYour cholesterol levels. Questions or concerns
Because you have high cholesterol you should: Know your cholesterol levels Take the medicine to lower cholesterol that your doctor has told you to take Follow your doctor s treatment plan Keep your appointments
More informationTrends in Retail Prices of Generic Prescription Drugs Widely Used by Older Americans, 2006 to 2015
SEPTEMBER 2017 Rx Price Watch Report Trends in Retail Prices of Generic Prescription Drugs Widely Used by Older Americans, 2006 to 2015 Stephen W. Schondelmeyer PRIME Institute, University of Minnesota
More informationPublic Assessment Report. Scientific discussion. Desloratadine Lek 5 mg film-coated tablets. (Desloratadine) DK/H/2041/001/DC.
Public Assessment Report Scientific discussion Desloratadine Lek 5 mg film-coated tablets (Desloratadine) DK/H/2041/001/DC 29 February 2016 This module reflects the scientific discussion for the approval
More informationNext Generation Lipid Modification in Cardiovascular Disease
TM Next Generation Lipid Modification in Cardiovascular Disease Investor Presentation Nasdaq: AMRN www.amarincorp.com 1 Forward-Looking Statement This presentation contains forward-looking statements,
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Reference Number: CP.HNMC.05 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy for important
More informationAbacavir (as sulfate) 300 mg tablets WHOPAR part 6 May 2016 (Hetero Labs Ltd), HA575
This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1
More informationThe Weekly Mortar & Pestle
The Weekly Mortar & Pestle A Publication of Walgreens Health Initiatives February 7, 2008 A publication created especially for our clients and associates, delivering up-to-date information about brand-name
More informationGuideline for Bioequivalence Studies of Generic Products
English translation of Attachment 1 of Division-tification 0229. 10 of the Pharmaceutical and Food Safety Bureau, dated February 29, 2012 Guideline for Bioequivalence Studies of Generic Products Index
More informationDecentralised Procedure. Public Assessment Report. Metamizol Midas / Metamizol STADA / Mimetanal 500 mg Tabletten. Metamizole sodium monohydrate
Decentralised Procedure Public Assessment Report Metamizol Midas / Metamizol STADA / Mimetanal 500 mg Tabletten Metamizole sodium monohydrate DE/H/4091-4093/001/DC Applicant: Midas Pharma GmbH, Germany
More informationAPPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 34 th EDITION THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. U.S. DEPARTMENT
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationA Review Article on Bioavailability and Bioequivalence Studies
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.5, No.4, pp 1711-1721, Oct-Dec 2013 A Review Article on Bioavailability and Bioequivalence Studies Srivastav Atul Kumar*,
More informationPharmacology of generics. Dario Cattaneo Unit of Clinical Pharmacology Luigi Sacco University Hospital, Milano, ITALY
Pharmacology of generics Dario Cattaneo Unit of Clinical Pharmacology Luigi Sacco University Hospital, Milano, ITALY Generics are effective drugs -Laurent, Lancet 2004 - that have improved access to therapy
More informationPublic Assessment Report. Scientific discussion. Ropinirol Actavis. Ropinirole hydrochloride DK/H/1212/ /DC
Public Assessment Report Scientific discussion Ropinirol Actavis Ropinirole hydrochloride DK/H/1212/001-007/DC This module reflects the scientific discussion for the approval of Ropinirole film-coated
More informationInformation for Vermont Prescribers of Prescription Drugs
Information for Vermont Prescribers of Prescription Drugs ZOLOFT (sertraline hydrochloride) tablets, for oral use This list does not imply that the products on this chart are interchangeable or have the
More informationLipid Management Step Therapy Criteria with Medical Diagnoses Option*
Lipid Management Step Therapy Criteria with Medical Diagnoses Option* * Medical diagnoses are required for implementation of this option. Program may be implemented with the following options: Option One
More informationTELECONFERENCE FY February 2015
TELECONFERENCE FY 2014 5 February 2015 Company disclaimer This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions,
More informationChina Oral Hypoglyceimic Agents (OHAs) Industry Report, Feb. 2011
China Oral Hypoglyceimic Agents (OHAs) Industry Report, 2010 Feb. 2011 This report Analyzes the status quo and prospect of Chinese OHAS Market. Related Products China Interventional Cardiovascular Device
More informationPUBLIC ASSESSMENT REPORT Scientific Discussion
Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion Tramadol hydrochloride + paracetamol 37.5 mg-325 mg Grünenthal film coated tablets Bonoc
More informationPharmacy Costs: Can I Make a Difference?
Pharmacy Costs: Can I Make a Difference? Pharmaceutical Market Dynamics What is driving Rx cost up? No New Blockbusters Patent Expirations OTC Market Dynamics Availability Pharmaceutical Companies Unfortunately,
More informationNOV
DEPARTMENT OF HEALTH &, HUMAN SERVICES ------------------------------------------ NOV 17 2010 Food and Drug Administration Rockville M D 20857 Mark S. Aikman, Pharm.D. Vice President, Regulatory Affairs
More informationPar Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (Fed. Cir. December 3, 2014)
Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (Fed. Cir. December 3, 2014) Chad M. Rink Birch, Stewart, Kolasch & Birch, LLP February 25, 2015 Background In 1993, Bristol-Myers Squibb began selling
More informationInternational Pharmaceutical Aerosol Consortium on Regulation and Science
International Pharmaceutical Aerosol Consortium on Regulation and Science 1500 K Street NW Washington DC 20005 Telephone +1 202 230 5607 Fax +1 202 842 8465 Email info@ipacrs.org Web www.ipacrs.org Submitted
More informationClinical Policy: Ezetimibe (Zetia) Reference Number: CP.PMN.78 Effective Date: Last Review Date: 02.19
Clinical Policy: (Zetia) Reference Number: CP.PMN.78 Effective Date: 02.01.17 Last Review Date: 02.19 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More information