82 FR 81 pgs. 19735-19737 - Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Type: NOTICEVolume: 82Number: 81Pages: 19735 - 19737
Docket number: [Docket No. FDA-2017-N-1551]
FR document: [FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 19735, 19736, 19737

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1551]

Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, Stacy.Kane@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA 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. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

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 NDA or ANDA 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 314.162).


[top] Under §?314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs 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 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or page 19736 effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs 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.

page 19737


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Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant
NDA 005010 DEMEROL Meperidine Hydrochloride 50 milligrams (mg)/5 milliliter (mL) Syrup; Oral U.S. Pharmaceutical Holdings II, LLC.
NDA 006035 METHERGINE Methylergonovine Maleate 0.2 mg Tablet; Oral Edison Therapeutics LLC.
NDA 007337 PERCODAN and PERCODAN-DEMI Aspirin, Oxycodone Hydrochloride, Oxycodone Terephthalate 325 mg, 4.5 mg, 0.38 mg; and 325 mg, 2.25 mg, 0.19 mg Tablet; Oral Endo Pharmaceuticals Inc.
NDA 008720 LEVO-DROMORAN Levorphanol Tartrate 2 mg Tablet; Oral Valeant Pharmaceuticals North America LLC.
NDA 008848 PAMINE and PAMINE FORTE Methscopolamine Bromide 2.5 mg and 5 mg Tablet; Oral Fougera Pharmaceuticals Inc.
NDA 009470 XYLOCAINE VISCOUS Lidocaine Hydrochloride 2% Solution; Oral Fresenius Kabi USA, LLC.
NDA 010485 ATARAX Hydroxyzine Hydrochloride 10 mg/5 mL Syrup; Oral Pfizer Inc.
NDA 010742 COMPAZINE Prochlorperazine Edisylate Equivalent to (EQ) 5 mg Base/mL Injectable; Injection GlaxoSmithKline.
NDA 012111 MYDRIACYL Tropicamide 0.5%; 1% Solution/Drops; Ophthalmic Alcon Laboratories Inc.
NDA 012248 PLEGINE Phendimetrazine Tartrate 35 mg Tablet; Oral Wyeth Ayerst Laboratories.
NDA 012365 SOMA COMPOUND Aspirin; Carisoprodol 325 mg; 200 mg Tablet; Oral Meda Pharmaceuticals Inc.
NDA 012366 SOMA COMPOUND W/CODEINE Aspirin; Carisoprodol; Codeine Phosphate 325 mg; 200 mg; 16 mg Tablet; Oral Ditto.
NDA 016012 VIVACTIL Protriptyline Hydrochloride 5 mg; 10 mg Tablet; Oral Teva Women's Health, Inc.
NDA 017352 FASTIN Phentermine Hydrochloride 30 mg Capsule; Oral GlaxoSmithKline.
NDA 017690 IMODIUM Loperamide Hydrochloride 2 mg Capsule; Oral Johnson & Johnson Consumer Inc.
NDA 017694 IMODIUM Loperamide Hydrochloride 2 mg Capsule; Oral Ditto.
NDA 017741 FLORONE Diflorasone Diacetate 0.05% Cream; Topical Pharmacia and Upjohn Co.
NDA 017802 LO/OVRAL-28 Ethinyl Estradiol; Norgestrel 0.03 mg; 0.3 mg Tablet; Oral-28 Wyeth Pharmaceuticals Inc.
NDA 017857 STADOL Butorphanol Tartrate 2 mg/mL Injectable; Injection Delcor Asset Corporation.
NDA 017857 STADOL PRESERVATIVE FREE Butorphanol Tartrate 1 mg/mL; 2 mg/mL Injectable; Injection Ditto.
NDA 018342 WELLCOVORIN Leucovorin Calcium EQ 5 mg Base; EQ 25 mg Base Tablet; Oral GlaxoSmithKline.
NDA 018353 FLAGYL I.V. Metronidazole Hydrochloride EQ 500 mg Base/Vial Injectable; Injection G.D. Searle LLC, a subsidiary of Pfizer Inc.
NDA 018733 TALWIN NX Naloxone Hydrochloride; Pentazocine Hydrochloride EQ 0.5 mg Base; EQ 50 mg Base Tablet; Oral Sanofi-Aventis U.S. LLC.
NDA 019488 CARDENE Nicardipine Hydrochloride 20 mg; 30 mg Capsule; Oral Chiesi USA, Inc.
NDA 019578 MEFLOQUINE HYDROCHLORIDE Mefloquine Hydrochloride 250 mg Tablet; Oral U.S. Army Walter Reed Army Institute Research.
NDA 019591 LARIAM Mefloquine Hydrochloride 250 mg Tablet; Oral Hoffmann-La Roche Inc.
NDA 019735 FLOXIN Ofloxacin 200 mg; 300 mg; 400 mg Tablet; Oral Janssen Pharmaceuticals, Inc.
NDA 019890 STADOL Butorphanol Tartrate 1 mg/Spray Spray, Metered; Nasal Bristol-Myers Squibb Co.
NDA 020142 CATAFLAM Diclofenac Potassium 50 mg Tablet; Oral Novartis Pharmaceuticals Corp.
NDA 020254 VOLTAREN-XR Diclofenac Sodium 100 mg Extended-Release Tablet; Oral Ditto.
NDA 020312 UNIVASC Moexipril Hydrochloride 7.5 mg; 15 mg Tablet; Oral UCB, Inc.
NDA 020346 ZYRTEC Cetirizine Hydrochloride 5 mg/5 mL Syrup; Oral Johnson & Johnson Consumer Inc.
NDA 020584 LODINE XL Etodolac 400 mg; 500 mg; 600 mg Extended-Release Tablet; Oral Wyeth Pharmaceuticals Inc.
NDA 020625 ALLEGRA Fexofenadine Hydrochloride 60 mg Capsule; Oral Sanofi-Aventis U.S. LLC.
NDA 020729 UNIRETIC Hydro chlorothiazide; Moexipril Hydrochloride 12.5 mg/7.5 mg; 12.5 mg/15 mg; 25 mg/15 mg Tablet; Oral UCB, Inc.
NDA 021066 ZADITOR Ketotifen Fumarate EQ 0.025% Base Solution/Drops; Ophthalmic Alcon Pharmaceuticals, Ltd.
NDA 021224 RAZADYNE Galantamine Hydrobromide 4 mg/mL Solution; Oral Janssen Pharmaceuticals, Inc.
NDA 021378 COMBUNO X Ibuprofen; Oxycodone Hydrochloride 400 mg; 5 mg Tablet; Oral Forest Laboratories, Inc.
NDA 021473 CIPRO XR Ciprofloxacin; Ciprofloxacin Hydrochloride 212.6 mg; EQ 287.5 mg Base; 425.2 mg; EQ 574.9 mg Base Extended-Release Tablet; Oral Bayer HealthCare Pharmaceuticals, Inc.
NDA 021606 ZEMPLAR Paricalcitol 4 micrograms (mcg) Capsule; Oral AbbVie Inc.
NDA 021729 ABILIFY Aripiprazole 10 mg and 15 mg Tablet, Orally Disintegrating; Oral Otsuka Pharmaceutical Co., Ltd.
NDA 050072 PENBRITIN-S Ampicillin Sodium EQ 125 mg Base/Vial; EQ 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 gram (g) Base/Vial; EQ 2 g Base/Vial; EQ 4 g Base/Vial Injectable; Injection Wyeth Ayerst Laboratories.
NDA 050309 POLYCILLIN-N Ampicillin Sodium EQ 125 mg Base/Vial; EQ 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/Vial Injectable; Injection Bristol Laboratories Inc.
NDA 050674 VANTIN Cefpodoxime Proxetil EQ 100 mg Base; EQ 200 mg Base Tablet; Oral Pharmacia and Upjohn Co.
ANDA 064170 CEFAZOLIN SODIUM Cefazolin Sodium EQ 10 g Base/Vial; EQ 20 g Base/Vial Injectable; Injection Fresenius Kabi USA, LLC.
ANDA 075406 OGESTREL 0.5/50-21 Ethinyl Estradiol; Norgestrel 0.05 mg; 0.5 mg Tablet; Oral-21 Watson Laboratories, Inc.
ANDA 085106 PERCOCET Acetaminophen; Oxycodone Hydrochloride 325 mg; 5 mg Tablet; Oral Vintage Pharmaceuticals LLC.
ANDA 089351 ROXICET Acetaminophen; Oxycodone Hydrochloride 325 mg/5 mL; 5 mg/5 mL Solution; Oral West-Ward Pharmaceuticals International Ltd.
ANDA 089456 PERPHENAZINE Perphenazine 8 mg Tablet; Oral ANI Pharmaceuticals, Inc.
ANDA 089457 PERPHENAZINE Perphenazine 16 mg Tablet; Oral Teva Pharmaceuticals USA.
ANDA 089707 PERPHENAZINE Perphenazine 2 mg Tablet; Oral Ditto.
ANDA 089708 PERPHENAZINE Perphenazine 4 mg Tablet; Oral Do.


FDA has reviewed its records and, under §?314.161, 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 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 ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs 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 ANDA 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, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

[FR Doc. 2017-08582 Filed 4-27-17; 8:45 am]

BILLING CODE 4164-01-P