83 FR 36 pgs. 7738-7740 - Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications
Type: NOTICEVolume: 83Number: 36Pages: 7738 - 7740
Pages: 7738, 7739Docket number: [Docket No. FDA-2018-N-0508]
FR document: [FR Doc. 2018-03607 Filed 2-21-18; 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-2018-N-0508]
Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 38 new drug applications (NDAs) and 43 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:
Approval is withdrawn as of March 26, 2018.
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 under 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 010151 | Dilantin (phenytoin sodium) Injection USP, 50 milligrams (mg)/milliliter (mL) | Parke-Davis, Subsidiary of Pfizer, Inc., 235 East 42nd St., New York, NY 10017. |
| NDA 011903 | Zolyse (chymotrypsin) for Ophthalmic Solution, 750 units/vial | Alcon Laboratories, Inc., 6201 S. Freeway, TC-45, Fort Worth, TX 76134-2099. |
| NDA 012125 | Carbocaine (mepivacaine hydrochloride (HCl)) Injection USP, 3% Carbocaine with Neo-Cobefrin (mepivacaine HCl; levonordefrin) Injection USP, 2%; 0.05 mg/mL | Hospira Inc., 8401 W. 102nd St., Pleasant Prairie, WI 53158. |
| NDA 012516 | Sansert (methysergide maleate) Tablets, 2 mg | Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936-1080. |
| NDA 016774 | Serentil (mesoridazine besylate) Tablets, Equivalent to (EQ) 10 mg base, 25 mg base, 50 mg base, and 100 mg base | Do. |
| NDA 016775 | Serentil (mesoridazine besylate) Injection, EQ 25 mg base/mL | Do. |
| NDA 016793 | Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial | Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| NDA 016997 | Serentil (mesoridazine besylate) Oral Concentrate, EQ 25 mg base/mL | Novartis Pharmaceuticals Corp. |
| NDA 017364 | Aquatensen (methyclothiazide) Tablets USP, 5 mg | Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. |
| NDA 017575 | DTIC-Dome (dacarbazine) for Injection, 100 mg/vial and 200 mg/vial | Bayer Healthcare Pharmaceuticals, Inc., 100 Bayer Blvd., Whippany, NJ 07981. |
| NDA 017717 | Gyne-Lotrimin (clotrimazole) Vaginal Tablets, 100 mg | Bayer HealthCare, LLC, 100 Bayer Blvd., P.O. Box 915, Whippany, NJ 07981-0915. |
| NDA 017869 | Funduscein-25 (fluorescein sodium) Injection, 25% | Novartis Pharmaceuticals Corp. |
| NDA 017993 | Hydergine (ergoloid mesylates) Tablets, 0.5 mg and 1 mg | Do. |
| NDA 018052 | Gyne-Lotrimin (clotrimazole) Vaginal Cream, 1% | Bayer HealthCare, LLC. |
| NDA 018128 | Ovcon-50 (norethindrone and ethinyl estradiol) Tablets USP (21-Day Regimen), 1 mg and 0.05 mg | Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, 100 Enterprise Dr., Rockaway, NJ 07866. |
| NDA 018397 | Chlor-Trimeton (chlorpheniramine maleate and pseudoephedrine sulfate) Extended-Release Tablets, 8 mg and 120 mg | Bayer HealthCare, LLC. |
| NDA 018418 | Hydergine (ergoloid mesylates) Oral Solution, 1 mg/mL | Novartis Pharmaceuticals Corp. |
| NDA 018439 | Multi-Vitamins Concentrate for Infusion, Injection | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| NDA 018471 | Ocuclear (oxymetazoline HCl) Ophthalmic Solution, 0.025% | Bayer HealthCare, LLC. |
| NDA 018517 | Metronidazole Tablets USP, 250 mg and 500 mg | IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| NDA 018969 | Liposyn III 10% (soybean oil) Injection, 10% | Hospira, Inc. |
| NDA 020045 | Shade UVAGuard (avobenzone, octinoxate, oxybenzone) Lotion, 3%/7.5%/3% | Bayer HealthCare, LLC. |
| NDA 020289 | Gyne-Lotrimin Combination Pack (clotrimazole) Vaginal Cream and Vaginal Tablets, 1% and 100 mg | Do. |
| NDA 020421 | Femstat-3 (butoconazole nitrate) Vaginal Cream, 2% | Do. |
| NDA 020499 | Actron (ketoprofen) Tablets, 12.5 mg | Do. |
| NDA 020525 | Gyne-Lotrimin 3 (clotrimazole) Vaginal Tablets, 200 mg | Do. |
| NDA 020526 | Gyne-Lotrimin 3 Combination Pack (clotrimazole) Vaginal Cream and Vaginal Tablets, 1% and 200 mg | Do. |
| NDA 020574 | Gyne-Lotrimin 3 (clotrimazole) Vaginal Cream, 2% | Do. |
| NDA 020619 | Betoptic Pilo (betaxolol HCl; pilocarpine HCl) Ophthalmic Suspension, EQ 0.25% base; 1.75% | Alcon Laboratories, Inc. |
| NDA 020665 | Diovan (valsartan) Capsules, 80 mg and 160 mg | Novartis Pharmaceuticals Corp. |
| NDA 020807 | Refludan (lepirudin recombinant) for Injection, 50 mg/vial | Bayer HealthCare Pharmaceuticals, Inc. |
| NDA 020888 | Lotrimin AF (clotrimazole) Cream, 1% | Bayer HealthCare, LLC. |
| NDA 020889 | Lotrimin AF (clotrimazole) Lotion, 1% | Do. |
| NDA 020890 | Lotrimin AF (clotrimazole) Topical Solution, 1% | Do. |
| NDA 021257 | Travatan (travoprost) Ophthalmic Solution, 0.004% | Alcon Pharmaceuticals, Ltd., 6201 S. Freeway, TC-45, Fort Worth, TX 76134. |
| NDA 021711 | Ablavar (gadofosveset trisodium) Injection, 2440 mg/10 mL and 3660 mg/15 mL | Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., Building 300-2, North Billerica, MA 01862. |
| NDA 050081 | Poly-Pred (neomycin sulfate; polymyxin B sulfate; prednisolone acetate) Ophthalmic Suspension, EQ 0.35% base; 10,000 units/mL; 0.5% | Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534. |
| ANDA 061758 | Penicillin V Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | Purepac Pharm., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 061980 | Ampicillin Trihydrate for Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL | Do. |
| ANDA 063116 | Tobramycin Sulfate Injection USP, EQ 40 mg base/mL (Pharmacy Bulk Package) | Hospira, Inc. |
| ANDA 065057 | Cefaclor Extended-Release Tablets, EQ 500 mg base | World Gen, LLC, 120 Route 17 North, Suite 127, Paramus, NJ 07652. |
| ANDA 071295 | Atropine Injection, EQ 2 mg sulfate/0.7 mL | AbbVie, Inc., Dept. PA77/Bldg. AP30, 1 N. Waukegan Rd., North Chicago, IL 60064. |
| ANDA 071536 | Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg base | Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 071541 | N.E.E. 1/35 21-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg | LPI Holdings, Inc., 5000 Plaza on the Lake, No. 270, Austin, TX 78746. |
| ANDA 071542 | N.E.E. 1/35 28-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg | Do. |
| ANDA 071545 | Norcept-E 1/35 21-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg | Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869-0602. |
| ANDA 071546 | Norcept-E 1/35 28-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg | Do. |
| ANDA 071690 | Metoprolol Tartrate Tablets USP, 50 mg | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
| ANDA 071691 | Metoprolol Tartrate Tablets USP, 100 mg | Do. |
| ANDA 074633 | Atracurium Besylate Injection, 10 mg/mL (Single-dose Vials) | Hospira, Inc. |
| ANDA 074639 | Atracurium Besylate Injection, 10 mg/mL (Abboject Syringe) | Do. |
| ANDA 074929 | Etodolac Capsules USP, 300 mg | ECI Pharmaceuticals, LLC, 5311 NW 35th Terrace, Fort Lauderdale, FL 33309. |
| ANDA 075870 | Famotidine Injection, 10 mg/mL | Hospira, Inc. |
| ANDA 076058 | Midazolam HCl Syrup, EQ 2 mg base/mL | Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. |
| ANDA 083140 | Hydrocortisone Tablets, 20 mg | Nexgen Pharma, Inc., 46 Corporate Park, Suite 200, Irvine, CA 92606. |
| ANDA 083633 | Isoniazid Tablets, 300 mg | Sun Pharmaceutical Industries, Inc. |
| ANDA 083634 | Diphenhydramine HCl Capsules, 25 mg | Nexgen Pharma, Inc. |
| ANDA 084050 | Isoniazid Tablets, 100 mg | Do. |
| ANDA 084220 | Meprobamate Tablets, 200 mg | Do. |
| ANDA 084238 | Pentobarbital Sodium Tablets, 100 mg | Do. |
| ANDA 084487 | Phentermine HCl Capsules USP, 30 mg | Upsher-Smith Laboratories, LLC, 301 South Cherokee St., Denver, CO 80223. |
| ANDA 084589 | Meprobamate Tablets, 400 mg | Nexgen Pharma, Inc. |
| ANDA 084915 | Folic Acid Tablets, 1 mg | Do. |
| ANDA 085499 | Potassium Chloride for Injection Concentrate USP, 2 milliequivalents/mL | Baxter Healthcare Corp., 1620 Waukegan Rd., McGaw Park, IL 60085. |
| ANDA 085985 | Dimenhydrinate Tablets, 50 mg | Nexgen Pharma, Inc. |
| ANDA 086020 | Phendimetrazine Tartrate Tablets, 35 mg | Do. |
| ANDA 086187 | Brompheniramine Maleate Tablets, 4 mg | Do. |
| ANDA 086392 | Meclizine HCl Tablets, 25 mg (Chewable) | Do. |
| ANDA 086835 | Polaramine (dexchlorpheniramine maleate) Tablets, 2 mg | Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc. |
| ANDA 086837 | Polaramine (dexchlorpheniramine maleate) Syrup, 2 mg/5 mL | Do. |
| ANDA 087766 | Thioridazine HCl Oral Concentrate, 30 mg/mL | Alpharma US Pharms., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 087858 | Isoetharine Mesylate Metered Dose Inhaler, 0.34 mg/inhalation | Do. |
| ANDA 088430 | Phentermine HCl Capsules USP, 30 mg | Upsher-Smith Laboratories, LLC. |
| ANDA 089381 | Hydroxyzine HCl Tablets USP, 10 mg | Sun Pharmaceutical Industries, Inc. |
| ANDA 089382 | Hydroxyzine HCl Tablets USP, 25 mg | Do. |
| ANDA 089383 | Hydroxyzine HCl Tablets USP, 50 mg | Do. |
| ANDA 089481 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg | American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716. |
| ANDA 089482 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg | Do. |
| ANDA 089489 | Diphenhydramine HCl Capsules, 50 mg | Sun Pharmaceutical Industries, Inc. |
| ANDA 091258 | Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg | Do. |
| NDA 208056 | Dexilant Solutab (dexlansoprazole) Delayed-Release Orally Disintegrating Tablets, 30 mg | Takeda Pharmaceuticals U.S.A., Inc., One Takeda Pkwy., Deerfield, IL 60015. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of March 26, 2018. 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 March 26, 2018 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: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03607 Filed 2-21-18; 8:45 am]
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