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81 pgs. 19735-19737 - Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 - 19737Pages: 19735, 19736, 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
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Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.
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 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.
|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