Determination that DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug

Transcription

1 This document is scheduled to be published in the Federal Register on 04/28/2017 and available online at and on FDsys.gov P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1551] Determination that DEMEROL (Meperidine ) Injectable and Other Drug Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (As) that refer to these drug products, and it will allow FDA to continue to approve As that refer to the products as long as they meet relevant legal and regulatory requirements. Through this notice, FDA is hoping to stimulate the economy and increase the regulatory certainty with respect to generic versions of these drug products by confirming that generic versions of the subject drug products may continue to be marketed. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Ave., Bldg. 51, rm. 6236, Silver Spring, MD , , Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L ) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an A

2 2 procedure. A applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the listed drug, which is a version of the drug that was previously approved. A applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the Approved Drug Products With Therapeutic Equivalence Evaluations, which is generally known as the Orange Book. Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug s or A for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR ). Under (a) (21 CFR (a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an A that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and As that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and Section (d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the As that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed.

3 3 Application No Drug Name Active Ingredient(s) Strength(s) Dosage Form/Route DEMEROL Meperidine 50 milligrams Syrup; ()/5 milliliter (ml) METHERGINE Methylergonovine PERCODAN and PERCODAN- DEMI LEVO- DROMORAN PAMINE and PAMINE FORTE XYLOCAINE VISCOUS ATARAX COMPAZINE Maleate Aspirin, Oxycodone, Oxycodone Terephthalate Levorphanol Methscopolamine Bromide Lidocaine Hydroxyzine Prochlorperazine Edisylate Applicant U.S. Pharmaceutical Holdings II, LLC 0.2 Edison Therapeutics LLC 325, 4.5, Endo 0.38 ; and 325, 2.25, Valeant North America LLC. 2.5 and 5 Fougera 2% Solution; Fresenius Kabi USA, LLC 10 /5 ml Syrup; Pfizer Equivalent to (EQ) 5 Base/mL GlaxoSmithKline MYDRIACYL Tropicamide 0.5%; 1% Solution/Drops; Ophthalmic Alcon Laboratories PLEGINE Phendimetrazine 35 Wyeth Ayerst Laboratories SOMA Aspirin; 325 ; 200 Meda COMPOUND Carisoprodol SOMA COMPOUND W/CODEINE VIVACTIL FASTIN IMODIUM IMODIUM FLORONE LO/OVRAL-28 STADOL STADOL PRESERVATIVE FREE Aspirin; Carisoprodol; Codeine Phosphate Protriptyline Phentermine Loperamide Loperamide Diflorasone Diacetate Ethinyl Estradiol; Norgestrel Butorphanol Butorphanol 325 ; 200 ; 16 Ditto 5 ; 10 Teva Women s Health, 30 Capsule; GlaxoSmithKline 2 Capsule; Johnson & Johnson Consumer 2 Capsule; Ditto 0.05% Cream; Topical Pharmacia and Upjohn Co ; Wyeth 2 /ml Delcor Asset 1 /ml; 2 /ml Corporation Ditto

4 WELLCOVORIN Leucovorin Calcium EQ 5 Base; EQ 25 Base FLAGYL I.V. Metronidazole EQ 500 Base/Vial TALWIN NX CARDENE MEFLOQUINE HYDROCHLORI DE LARIAM Naloxone ; Pentazocine Nicardipine Mefloquine EQ 0.5 Base; EQ 50 Base Mefloquine FLOXIN Ofloxacin 200 ; 300 ; 400 STADOL CATAFLAM Butorphanol Diclofenac Potassium GlaxoSmithKline G.D. Searle LLC, a subsidiary of Pfizer Sanofi-Aventis U.S. LLC 20 ; 30 Capsule; Chiesi USA, 250 U.S. Army Walter Reed Army Institute Research 250 Hoffmann-La Roche Janssen, 1 /Spray Spray, Metered; Nasal Bristol-Myers Squibb Co. 50 Novartis Corp. VOLTAREN-XR Diclofenac Sodium 100 Extended- Release Tablet; UNIVASC ZYRTEC Moexipril Cetirizine LODINE XL Etodolac 400 ; 500 ; 600 ALLEGRA Fexofenadine UNIRETIC Hydro chlorothiazide; Moexipril ZADITOR Ketotifen Fumarate EQ 0.025% Base RAZADYNE COMBUNOX CIPRO XR Galantamine Hydrobromide Ibuprofen; Oxycodone Ciprofloxacin; Ciprofloxacin Ditto 7.5 ; 15 UCB, 5 /5 ml Syrup; Johnson & Johnson Extended- Release Tablet; Consumer Wyeth 60 Capsule; Sanofi-Aventis U.S. LLC 12.5 /7.5 UCB, ; 12.5 / 15 ; 25 /15 Solution/Drops; Ophthalmic Alcon, Ltd. 4 /ml Solution; Janssen, 400 ; 5 Forest Laboratories, ; EQ Base; ; EQ Base Extended- Release Tablet; Bayer HealthCare,

5 A A A A A A A A ZEMPLAR Paricalcitol 4 micrograms (mcg) ABILIFY Aripiprazole 10 and 15 PENBRITIN-S Ampicillin Sodium EQ gram (g) 2 g 4 g Base/Vial POLYCILLIN-N Ampicillin Sodium EQ g VANTIN CEFAZOLIN SODIUM Cefpodoxime Proxetil Cefazolin Sodium 2 g Base/Vial EQ 100 Base; EQ 200 Base EQ 10 g 20 g Base/Vial Capsule; Tablet, ly Disintegrating; AbbVie Otsuka Pharmaceutical Co., Ltd. Wyeth Ayerst Laboratories Bristol Laboratories Pharmacia and Upjohn Co. Fresenius Kabi USA, LLC OGESTREL 0.5/50-21 Ethinyl Estradiol; Norgestrel 0.05 ; Watson Laboratories, PERCOCET Acetaminophen; 325 ; 5 Vintage Oxycodone LLC ROXICET Acetaminophen; 325 /5 ml; 5 Solution; West-Ward Oxycodone /5 ml International Ltd. PERPHENAZINE Perphenazine 8 ANI, PERPHENAZINE Perphenazine 16 Teva USA PERPHENAZINE Perphenazine 2 Ditto PERPHENAZINE Perphenazine 4 Do. FDA has reviewed its records and, under , has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this

6 6 document in the Discontinued Drug Product List section of the Orange Book. The Discontinued Drug Product List identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved As that refer to the s and As listed in this document are unaffected by the discontinued marketing of the products subject to those s and As. Additional As that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise A applicants to submit such labeling. This is not a significant regulatory action subject to Executive Order 12866, and does not impose any additional burden on regulated entities. Dated: April 24, Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc Filed: 4/27/2017 8:45 am; Publication Date: 4/28/2017]