Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications
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1 This document is scheduled to be published in the Federal Register on 10/03/2017 and available online at and on FDsys.gov P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4563] 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD , 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 (c) (21 CFR (c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under (c) is without prejudice to refiling.
2 2 NDA ANDA NDA Delfen (nonoxynol-9) Contraceptive Foam, 12.5% Dextrose 60% Injection USP in Plastic Container Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg NDA Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8 mg NDA Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and 400 mg NDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA ANDA Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg and 40 mg Acetazolamide for Injection USP, Equivalent to (EQ) 500 mg base/vial Digoxin Injection USP, 0.25 mg/milliliter (ml) Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg Penicillin G Procaine for Injection, 300,000 units/vial and 1,500,000 units/vial Tobramycin Injection USP, EQ 40 mg base/ml Naloxone HCl Injection USP, 0.02 mg/ml Disopyramide Phosphate Capsules USP, EQ 100 mg base Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ 08558, 275 North Field Dr., Dept. 389, Bldg. H2-2, Lake Forest, IL AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg, MD Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH GlaxoSmithKline Intellectual Property Management LTD England, c/o GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ Pfizer Inc., 235 East 42nd St., New York, NY Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Propranolol HCl Tablets USP, 20 mg Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA ANDA Naloxone HCl Injection, 0.4 mg/ml ANDA Methyldopate HCl Injection USP, 50 mg/ml, ADD-Vantage Vial
3 3 ANDA Methyldopate HCl Injection USP, 50 mg/ml, Fliptop Vial ANDA Verapamil HCl Injection, 2.5 mg/ml, 2 ml Abbojet-PA Syringe ANDA Verapamil HCl Injection, 2.5 mg/ml, 4 ml Abbojet Syringe Vial ANDA Enflurane USP, 99.9% Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., D389, Bldg. J45-2, Abbott Park, IL ANDA Aminocaproic Acid Injection USP, 250 mg/ml ANDA Tolazamide Tablets USP, 100 mg Sun Pharmaceutical Industries, Inc. ANDA Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 ml ANDA Ritodrine HCl Injection USP, 10 mg/ml ANDA Ritodrine HCl Injection USP, 15 mg/ml ANDA Droperidol and Fentanyl Citrate Injection, 2.5 mg/ml and EQ 0.05 mg base/ml ANDA Pancuronium Bromide Injection, 2 mg/ml ANDA Sulfamethoxazole and Trimethoprim Injection USP, 80 mg/ml and 16 mg/ml ANDA Tolmetin Sodium Tablets USP, EQ 200 mg base ANDA CO-LAV (polyethylene glycol 3350 and electrolytes) for Oral Suspension ANDA GO-EVAC (polyethylene glycol 3350 and electrolytes) for Oral Suspension ANDA Carbastat (carbachol) Intraocular Solution, 0.01% ANDA ANDA ANDA ANDA ANDA Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg Lorazepam Injection USP, 2 mg/ml and 4 mg/ml Cimetidine HCl Injection, EQ 300 mg base/2 ml (Carpuject) Cimetidine HCl Injection, EQ 300 mg base/2 ml Cimetidine HCl Injection, EQ 300 mg base/2 ml, ADD-Vantage Vial Sun Pharmaceutical Industries, Inc. Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
4 4 ANDA 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 ANDA Butorphanol Tartrate Injection USP, 1 mg/ml and 2 mg/ml ANDA Acyclovir for Injection USP, EQ 500 mg base/vial and EQ 1 gram (g) base/vial ANDA Ketorolac Tromethamine Injection USP, 15 mg/ml and 30 mg/ml ANDA Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base ANDA Sotalol HCl Tablets USP, 80 mg, 120 mg, Teva Pharmaceuticals USA, Inc. and 160 mg ANDA Citalopram Hydrobromide Tablets, EQ Sun Pharmaceutical Industries, Inc. 10 mg base, EQ 20 mg base, and EQ 40 mg base ANDA Meloxicam Tablets, 7.5 mg and 15 mg ANDA Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg base, and EQ 10 mg base ANDA Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL ANDA Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg and 12.5 mg Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC ANDA Isoniazid Tablets, 100 mg Sun Pharmaceutical Industries, Inc. ANDA Prednisone Tablets USP, 5 mg Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD ANDA Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 ml; 540 mg/100 ml ANDA Potassium Chloride for Injection Concentrate USP, 1 milliequivalent (meq)/ml, 1.5 meq/ml, and 2 meq/ml ANDA Quinidine Sulfate Tablets USP, 200 mg Contract Pharmacal Corp., c/o SciRegs International Inc.
5 5 ANDA Chlordiazepoxide HCl Capsules USP, 10 mg Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN ANDA Chlordiazepoxide HCl Capsules USP, 5 mg ANDA Ogen (estropipate) Vaginal Cream USP, Pfizer Inc. 1.5 mg/g ANDA Folic Acid Tablets USP, 1 mg Contract Pharmacal Corp., c/o SciRegs International Inc. ANDA Phentermine HCl Tablets USP Lemmon Co., 650 Cathill Rd., Sellersville, PA ANDA Chlordiazepoxide HCl Capsules, 25 mg Teva Pharmaceuticals USA, Inc. ANDA Hydroxyzine HCl Injection USP, 50 mg/ml ANDA Hydroxyzine HCl Injection USP, 25 mg/ml, Carpuject ANDA Hydroxyzine HCl Injection USP, 50 mg/ml, Carpuject ANDA Hydroxyzine HCl Tablets USP, 100 mg Sun Pharmaceutical Industries, Inc. ANDA Aminophylline in Sodium Chloride 0.45% Injection, 100 mg/100 ml and 200 mg/100 ml ANDA Lidocaine HCl Injection USP, 10% ANDA Lidocaine HCl Injection USP, 4% ANDA Cyclopentolate HCl Ophthalmic Solution, 1% Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC-45, Fort Worth, TX ANDA Diatrizoate Meglumine and Diatrizoate Sodium Injection USP, 66%; 10% Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe Township, NJ ANDA Glycopyrrolate Injection USP, 0.2 mg/ml ANDA Diphenhydramine HCl Capsules, 25 mg Sun Pharmaceutical Industries, Inc. ANDA ANDA ANDA ANDA Phenytoin Sodium Injection USP, 50 mg/ml, Ampule Procainamide HCl Injection USP, 500 mg/ml, Carpuject Phenytoin Sodium Injection USP, 50 mg/ml, Carpuject Leucovorin Calcium for Injection, EQ 100 mg base/vial Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618
6 6 NDA Victrelis (boceprevir) Capsules, 200 mg Merck Sharp & Dohme Corp.,Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ NDA Vitekta (elvitegravir) Tablets, 85 mg and 150 mg Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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, Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc Filed: 10/2/2017 8:45 am; Publication Date: 10/3/2017]
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