82 FR 190 pgs. 46079-46081 - Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications
Type: NOTICEVolume: 82Number: 190Pages: 46079 - 46081
Pages: 46079, 46080, 46081Docket number: [Docket No. FDA-2017-N-4563]
FR document: [FR Doc. 2017-21177 Filed 10-2-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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:
[top] The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple
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.
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| 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.
[FR Doc. 2017-21177 Filed 10-2-17; 8:45 am]
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