2017-21177. Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES:

Withdrawal of approval is effective November 2, 2017.

FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION:

The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Application No.	Drug	Applicant
NDA 014349	Delfen (nonoxynol-9) Contraceptive Foam, 12.5%	Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ 08558.
ANDA 019346	Dextrose 60% Injection USP in Plastic Container	Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. H2-2, Lake Forest, IL 60045.
NDA 019810	Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg	AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg, MD 20878.
NDA 020184	Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8 mg	Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH 45227.
NDA 022345	Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and 400 mg	GlaxoSmithKline Intellectual Property Management LTD England, c/o GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA 19426.
NDA 021712	Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mg	UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.
ANDA 040108	Acetazolamide for Injection USP, Equivalent to (EQ) 500 mg base/vial	Hospira, Inc.
ANDA 040206	Digoxin Injection USP, 0.25 mg/milliliter (mL)	Do.
ANDA 040527	Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg	Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512.
ANDA 040899	Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg	Do.
ANDA 060099	Penicillin G Procaine for Injection, 300,000 units/vial and 1,500,000 units/vial	Pfizer Inc., 235 East 42nd St., New York, NY 10017.
ANDA 063161	Tobramycin Injection USP, EQ 40 mg base/mL	Hospira, Inc.
ANDA 070171	Naloxone HCl Injection USP, 0.02 mg/mL	Do.
ANDA 070186	Disopyramide Phosphate Capsules USP, EQ 100 mg base	Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 070233	Propranolol HCl Tablets USP, 20 mg	Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 070255	Naloxone HCl Injection, 0.4 mg/mL	Hospira, Inc.
ANDA 070698	Methyldopate HCl Injection USP, 50 mg/mL, ADD-Vantage Vial	Do.
ANDA 070699	Methyldopate HCl Injection USP, 50 mg/mL, Fliptop Vial	Do.
ANDA 070739	Verapamil HCl Injection, 2.5 mg/mL, 2 mL Abbojet-PA Syringe	Do.
ANDA 070740	Verapamil HCl Injection, 2.5 mg/mL, 4 mL Abbojet Syringe Vial	Do.
ANDA 070803	Enflurane USP, 99.9%	Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., D389, Bldg. J45-2, Abbott Park, IL 60064.
ANDA 070888	Aminocaproic Acid Injection USP, 250 mg/mL	Hospira, Inc.
ANDA 071357	Tolazamide Tablets USP, 100 mg	Sun Pharmaceutical Industries, Inc.
ANDA 071438	Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 mL	Hospira, Inc.
ANDA 071618	Ritodrine HCl Injection USP, 10 mg/mL	Do.
ANDA 071619	Ritodrine HCl Injection USP, 15 mg/mL	Do.
ANDA 071982	Droperidol and Fentanyl Citrate Injection, 2.5 mg/mL and EQ 0.05 mg base/mL	Do.
ANDA 072321	Pancuronium Bromide Injection, 2 mg/mL	Do.
ANDA 073199	Sulfamethoxazole and Trimethoprim Injection USP, 80 mg/mL and 16 mg/mL	Do.
ANDA 073310	Tolmetin Sodium Tablets USP, EQ 200 mg base	Sun Pharmaceutical Industries, Inc.
ANDA 073428	CO-LAV (polyethylene glycol 3350 and electrolytes) for Oral Suspension	Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 073433	GO-EVAC (polyethylene glycol 3350 and electrolytes) for Oral Suspension	Do.
ANDA 073677	Carbastat (carbachol) Intraocular Solution, 0.01%	Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936.
ANDA 074168	Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg	Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 074280	Lorazepam Injection USP, 2 mg/mL and 4 mg/mL	Hospira, Inc.
ANDA 074296	Cimetidine HCl Injection, EQ 300 mg base/2 mL (Carpuject)	Do.
ANDA 074412	Cimetidine HCl Injection, EQ 300 mg base/2 mL	Do.
ANDA 074422	Cimetidine HCl Injection, EQ 300 mg base/2 mL, ADD-Vantage Vial	Do.
ANDA 074468	Cimetidine HCl in Sodium Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg base/100 mL, EQ 360 mg/100 mL, and EQ 480 mg base/100 mL	Do.
ANDA 074620	Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/mL	Do.
ANDA 074758	Acyclovir for Injection USP, EQ 500 mg base/vial and EQ 1 gram (g) base/vial	Do.
ANDA 074801	Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL	Do.
ANDA 075385	Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg	Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
ANDA 075453	Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base	Do.
ANDA 076883	Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg	Teva Pharmaceuticals USA, Inc.
ANDA 077052	Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base	Sun Pharmaceutical Industries, Inc.
ANDA 077937	Meloxicam Tablets, 7.5 mg and 15 mg	Do.
ANDA 078081	Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg base, and EQ 10 mg base	Do.
ANDA 078158	Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL	Hospira, Inc.
ANDA 078483	Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg and 12.5 mg	Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC 27703.
ANDA 080136	Isoniazid Tablets, 100 mg	Sun Pharmaceutical Industries, Inc.
ANDA 080209	Prednisone Tablets USP, 5 mg	Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD 21045.
ANDA 080224	Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 mg/100 mL	Hospira, Inc.
ANDA 083345	Potassium Chloride for Injection Concentrate USP, 1 milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL	Do.
ANDA 083808	Quinidine Sulfate Tablets USP, 200 mg	Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 084623	Chlordiazepoxide HCl Capsules USP, 10 mg	Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 084644	Chlordiazepoxide HCl Capsules USP, 5 mg	Do.
ANDA 084710	Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g	Pfizer Inc.
ANDA 085061	Folic Acid Tablets USP, 1 mg	Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 085933	Phentermine HCl Tablets USP	Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.
ANDA 086494	Chlordiazepoxide HCl Capsules, 25 mg	Teva Pharmaceuticals USA, Inc.
ANDA 086821	Hydroxyzine HCl Injection USP, 50 mg/mL	Hospira, Inc.
ANDA 087416	Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject	Do.
ANDA 087546	Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject	Do.
ANDA 087862	Hydroxyzine HCl Tablets USP, 100 mg	Sun Pharmaceutical Industries, Inc.
ANDA 088147	Aminophylline in Sodium Chloride 0.45% Injection, 100 mg/100 mL and 200 mg/100 mL	Hospira, Inc.
ANDA 088367	Lidocaine HCl Injection USP, 10%	Do.
ANDA 088542	Lidocaine HCl Injection USP, 4%	Do.
ANDA 089162	Cyclopentolate HCl Ophthalmic Solution, 1%	Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC-45, Fort Worth, TX 76134.
ANDA 089347	Diatrizoate Meglumine and Diatrizoate Sodium Injection USP, 66%; 10%	Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ 08831.
ANDA 089393	Glycopyrrolate Injection USP, 0.2 mg/mL	Hospira, Inc.
ANDA 089488	Diphenhydramine HCl Capsules, 25 mg	Sun Pharmaceutical Industries, Inc.
ANDA 089521	Phenytoin Sodium Injection USP, 50 mg/mL, Ampule	Hospira, Inc.
ANDA 089537	Procainamide HCl Injection USP, 500 mg/mL, Carpuject	Do.
ANDA 089744	Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject	Do.
ANDA 089915	Leucovorin Calcium for Injection, EQ 100 mg base/vial	Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618.
NDA 202258	Victrelis (boceprevir) Capsules, 200 mg	Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 203093	Vitekta (elvitegravir) Tablets, 85 mg and 150 mg	Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective November 2, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on the date that this notice becomes effective (see DATES) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

Dated: September 27, 2017.

Anna K. Abram,

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