2016-27855. Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

FOR FURTHER INFORMATION CONTACT:

Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [e-mail].

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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30.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 007898	BENEMID	Probenecid	500 milligrams (mg)	Tablet; Oral	Merck and Co., Inc.
NDA 008048	XYLOCAINE	Lidocaine	5%	Ointment; Topical	AstraZeneca Pharmaceuticals LP.
NDA 011111	VISTARIL	Hydroxyzine Hydrochloride (HCl)	25 mg/milliliter (mL); 50 mg/mL	Injectable; Injection	Pfizer Inc.
NDA 012209	FLUOROURACIL	Fluorouracil	500 mg/10 mL (50 mg/mL)	Injectable; Injection	Spectrum Pharmaceuticals, Inc.
NDA 013220	PERIACTIN	Cyproheptadine HCl	2 mg/5 mL	Syrup; Oral	Merck and Co., Inc.
NDA 017534	FIORINAL	Aspirin; Butalbital; Caffeine	325 mg; 50 mg; 40 mg	Tablet; Oral	Allergan Sales, LLC.
NDA 017577	DITROPAN	Oxybutynin Chloride	5 mg	Tablet; Oral	Ortho-McNeil-Janssen Pharmaceuticals, Inc.
NDA 017781	DIPROSONE	Betamethasone Dipropionate	Equivalent to (EQ) 0.05% Base	Lotion; Topical	Schering Corp.
NDA 018211	DITROPAN	Oxybutynin Chloride	5 mg/5 mL	Syrup; Oral	Ortho-McNeil-Janssen Pharmaceuticals, Inc.
NDA 018586	TOPICORT	Desoximetasone	0.05%	Gel; Topical	Taro Pharmaceuticals U.S.A., Inc.
NDA 018631	TRENTAL	Pentoxifylline	400 mg	Extended-Release Tablet; Oral	U.S. Pharmaceutical Holdings II, LLC.
NDA 019155	LAC-HYDRIN	Ammonium Lactate	EQ 12% Base	Lotion; Topical	Ranbaxy Laboratories Inc.
NDA 019323	TEMOVATE	Clobetasol Propionate	0.05%	Ointment; Topical	Fougera Pharmaceuticals Inc.
NDA 019778	PRINZIDE	Hydrochlorothiazide; Lisinopril	12.5 mg/10 mg; 12.5mg/20mg	Tablet; Oral	Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc.
NDA 019842	MOTRIN	Ibuprofen	100 mg/5 mL	Suspension; Oral	McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
NDA 019915	MONOPRIL	Fosinopril Sodium	10 mg; 20 mg; 40 mg	Tablet; Oral	Bristol-Myers Squibb Co.
NDA 020343	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	Milrinone Lactate	EQ 10 mg Base/100 mL; EQ 15 mg Base/100 mL; EQ 20 mg Base/100 mL; EQ 40 mg Base/200 mL	Injectable; Injection	Sanofi-Aventis U.S. LLC.
NDA 020508	LAC-HYDRIN	Ammonium Lactate	EQ 12% Base	Cream; Topical	Ranbaxy Laboratories, Inc.
NDA 020635	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	Levofloxacin	EQ 250 mg/50 mL (EQ 5 mg/mL); EQ 500 mg/100 mL (EQ 5 mg/mL); EQ 750 mg/150 mL (EQ 5 mg/mL)	Injectable; Injection	Janssen Pharmaceuticals, Inc.
NDA 020863	PLETAL	Cilostazol	50 mg; 100 mg	Tablet; Oral	Otsuka Pharmaceutical Co., Ltd.
NDA 20950	DUONEB	Albuterol Sulfate; Ipratropium Bromide	EQ 0.083% Base; 0.017%	Solution; Inhalation	Mylan Specialty, L.P.
NDA 21460	METAGLIP	Glipizide; Metformin HCl	2.5 mg/250 mg; 2.5 mg/500 mg; 5 mg/500 mg	Tablet; Oral	Bristol-Myers Squibb Co.
NDA 021759	ELOXATIN	Oxaliplatin	200 mg/40 mL (5 mg/mL)	Injectable; Intravenous (Infusion)	Sanofi-Aventis U.S. LLC.
NDA 050442	VIBRAMYCIN	Doxycycline Hyclate	EQ 100 mg Base/Vial; EQ 200 mg Base/Vial	Injectable; Injection	Pfizer Inc.
NDA 050624	ROCEPHIN W/DEXTROSE IN PLASTIC CONTAINER	Ceftriaxone Sodium	EQ 10 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/mL	Injectable; Injection	Hoffmann-La Roche, Inc.
NDA 050739	OMNICEF	Cefdinir	300 mg	Capsule; Oral	AbbVie Inc.
NDA 050749	OMNICEF	Cefdinir	125 mg/5 mL; 250 mg/5 mL	For Suspension; Oral	AbbVie Inc.
ANDA 060003	V-CILLIN K	Penicillin V Potassium	EQ 125 mg Base; EQ 250 mg Base; EQ 500 mg Base	Tablet; Oral	Eli Lilly and Company.
ANDA 060463	GARAMYCIN	Gentamicin Sulfate	EQ 0.1% Base	Ointment; Topical	Schering-Plough Corp.
ANDA 086833	CYPROHEPTADINE HYDROCHLORIDE	Cyproheptadine HCl	2 mg/5mL	Syrup; Oral	Actavis Mid Atlantic LLC.
ANDA 088877	BENZTROPINE MESYLATE	Benztropine Mesylate	0.5 mg	Tablet; Oral	Lannett Holdings, Inc.
ANDA 088894	BENZTROPINE MESYLATE	Benztropine Mesylate	1 mg	Tablet; Oral	Lannett Holdings, Inc.
ANDA 088895	BENZTROPINE MESYLATE	Benztropine Mesylate	2 mg	Tablet; Oral	Lannett Holdings, Inc.

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.

Dated: November 14, 2016.

Leslie Kux,

Associate Commissioner for Policy.