Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0190]

Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 35 new drug applications (NDAs) and 64 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:

Effective Date:

April 18, 2012.

FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION:

The holders of the applications listed in table 1 in this document 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.

Table 1

Application No.

Drug

Applicant

NDA 005545

Dicumarol Tablets

Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.

NDA 005845

Benadryl (diphenhydramine hydrochloride (HCl)), Benadryl with Ephedrine Sulfate, and Caladryl (diphenhydramine HCl and calamine)

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.

NDA 006146

Benadryl (diphenhydramine HCl)) Injection

Do.

NDA 006773

Artane (trihexyphenidyl HCl) Tablets and Capsules and Artane (trihexyphenidyl) Elixir

Lederle Laboratories, d/b/a Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299.

NDA 009486

Benadryl (diphenhydramine HCl)) Injection Preservative Free

McNeil Consumer Healthcare.

NDA 010021

Placidyl (ethchlorvynol) Capsules

Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60064.

NDA 011552

Stelazine (trifluoperazine HCl)

GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.

NDA 012524

Enduron (methyclothiazide) Tablets, 2.5 milligrams (mg) and 5 mg

Abbott Laboratories, PA77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.

NDA 012775

Enduronyl and Enduronyl Forte (methyclothiazide and deserpidine) Tablets

Do.

NDA 014684

Aventyl (nortriptyline HCl) Capsules

Eli Lilly and Co., Lilly Corp. Center, Indianapolis, IN 46285.

NDA 017577

Ditropan (oxybutynin chloride) Tablets

Janssen Pharmaceuticals Inc., c/o Johnson & Johnson Pharmaceutical Research and Development, LLC, 920 Route 202, P.O. Box 300, Raritan, NJ 08869.

NDA 018473

Ventolin (albuterol) Inhalation Aerosol

1

GlaxoSmithKline.

NDA 018557

Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 mg and 25 mg

Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199.

NDA 018709

Capozide (captopril and hydrochlorothiazide) Tablets

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.

NDA 018814

Heparin Sodium in 5% Dextrose Injection

Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085.

NDA 019297

Novantrone (mitoxantrone HCl) Injection

EMD Serono, One Technology Place, Rockland, MA 02370.

NDA 019508

Axid (nizatidine) Capsules

SmithKline Beecham Corp., d/b/a GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.

NDA 019915

Monopril (fosinopril sodium) Tablets, 10 mg, 20 mg, and 40 mg

Bristol-Myers Squibb Co.

NDA 019946

Nuromax (doxacurium chloride) Injection 1 mg/milliliter (mL)

Abbott Laboratories, P76/Bldg. AP30-1E, Abbott Park, IL 60064-6157.

NDA 019960

Manoplax (flosequinan) Tablets

Do.

NDA 020057

Ceredase (alglucerase) Injection

Genzyme Corp., 500 Kendall St., Cambridge, MA 02142.

NDA 020088

Norplant System (levonorgestrel) Implants

Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299.

NDA 020101

Prozac (fluoxetine HCl) Oral Solution, 20 mg/5 mL

Eli Lilly and Co.

NDA 020236

Serevent (salmeterol xinafoate) Inhalation Aerosol

1

GlaxoSmithKline.

NDA 020286

Monopril-HCT (fosinopril sodium and hydrochlorothiazide) Tablets, 20 mg/12.5 mg and 10 mg/12.5 mg

Bristol-Myers Squibb Co.

NDA 020403

Zofran (ondansetron HCl) Injection

Glaxo Wellcome Manufacturing Pte Limited, d/b/a GlaxoSmithKline, 1250 Collegeville Rd., UP4110, Collegeville, PA 19426.

NDA 020627

Norplant II System (levonorgestrel) Implants

Wyeth Pharmaceuticals, Inc.

NDA 020828

Fortovase (saquinavir) Capsules, 200 mg

Hoffman-La Roche, Inc.

NDA 020860

Levlite (ethinyl estradiol and levonorgestrel) Tablets

Bayer HealthCare Pharmaceuticals Inc., P.O. Box 1000, Montville, NJ 07045.

NDA 020984

Raplon (rapacuronium bromide) for Injection

Organon USA Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.

NDA 021120

Novantrone (mitoxantrone HCl) Injection

EMD Serono.

NDA 021793

Reglan ODT (metoclopramide) Tablets

Meda Pharmaceuticals Inc., 200 North Cobb Parkway, Suite 428, Marietta, GA 30062.

ANDA 040207

Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg

Duramed Pharmaceuticals, Inc., 400 Chestnut Rd., Woodcliff Lake, NJ 07677.

ANDA 040231

Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL

Pharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605.

NDA 050526

Staticin (erythromycin) Topical Solution, 1.5%

Bristol-Myers Squibb Co.

NDA 050687

Banan (cefpodoxime proxetil) Tablets, 100 mg and 200 mg

Daiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837.

NDA 050688

Banan (cefpodoxime proxetil) Granules for Oral Suspension, 50 mg/5 mL and 100 mg/5 mL

Do.

ANDA 064098

Amikacin Sulfate Injection USP, 250 mg (base)/mL

Hospira, Inc., 275 North Field Dr., Bldg. H2-2, Lake Forest, IL 60045.

ANDA 064106

Mitomycin for Injection USP, 20 mg Vial

Do.

ANDA 070505

Metoclopramide Injection USP, 5 mg/mL

Do.

ANDA 070506

Metoclopramide Injection USP, 5 mg/mL

Do.

ANDA 070566

Nitropress (sodium nitroprusside for Injection USP), 50 mg

Do.

ANDA 071015

Haloperidol Oral Solution USP, 2 mg/mL

Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454.

ANDA 071554

Thiothixene HCl Oral Solution USP, 5 mg/mL

Do.

ANDA 073058

Fluphenazine HCl Oral Solution USP, 5 mg/mL

Do.

ANDA 073479

Pentamidine Isethionate for Injection, 300 mg Vial

Hospira, Inc.

ANDA 074636

Iopamidol Injection USP, 41%, 51%, 61%, 76%

Do.

ANDA 074898

Iopamidol Injection USP, 41%, 51%, 61%, 76%

Do.

ANDA 075065

Acyclovir Sodium for Injection

Do.

ANDA 075176

Haloperidol Decanoate Injection, 50 mg/mL and 100 mg/mL

Do.

ANDA 075409

Midazolam HCl Injection, 1 mg (base)/mL and 5 mg (base)/mL

Do.

ANDA 075884

Milrinone Lactate Injection, 1 mg/mL

Do.

ANDA 076306

Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg

Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.

ANDA 077138

Ciprofloxacin Injection USP in 5% Dextrose Injection

Teva Pharmaceuticals USA.

ANDA 077223

Terbinafine HCl Tablets, 250 mg (base)

Roxane Laboratories, Inc.

ANDA 077784

Risperidone Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg

Ratiopharm Inc., c/o Columbia Pharma Consulting Services Inc., 490 Northwest Datewood Dr., Suite 400, Issaquah, WA 98027.

ANDA 078241

Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 mg (base)

Roxane Laboratories, Inc.

ANDA 078318

Sumatriptan Injection, 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL

TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.

ANDA 078416

Prednisolone Sodium Phosphate Oral Solution, 5 mg (base)/5 mL

Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811.

ANDA 078517

Venlafaxine HCl Tablets, 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base)

PLIVA Hrvatska d.o.o., c/o Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677

ANDA 080997

Succinylcholine Chloride Injection USP, 20 mg/mL

Organon USA Inc.

ANDA 081125

Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL

TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.

ANDA 081126

Dexamethasone Sodium Phosphate Injection USP

Do.

ANDA 081298

Chlorzoxazone Tablets, 250 mg

Ranbaxy Inc., U.S. Agent for Ohm, 600 College Rd. East, Princeton, NJ 08540.

ANDA 081299

Chlorzoxazone Tablets, 500 mg

Do.

ANDA 081310

Fluphenazine HCl Elixir USP, 2.5 mg/5 mL

Teva Pharmaceuticals USA.

ANDA 087005

Trichlormethiazide Tablets, 4 mg

Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.

ANDA 087007

Trichlormethiazide Tablets, 2 mg

Do.

ANDA 087032

Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL

Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG, 6451 West Main St., Morton Grove, IL 60053.

ANDA 087053

Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL

Do.

ANDA 087406

Oxycodone and Acetaminophen Tablets USP, 5 mg/325 mg

Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.

ANDA 087585

Potassium Chloride for Injection Concentrate USP, 2 mEq/mL

Luitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O. Box 9001, Shirley, NY 11967.

ANDA 088143

Trifluoperazine Oral Solution USP, 10 mg/mL

Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.

ANDA 088194

Thioridazine HCl Tablets USP, 50 mg

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.

ANDA 088227

Thioridazine HCl Oral Solution USP (Concentrate), 100 mg/mL

Morton Grove Pharmaceuticals, Inc., U.S. Agent for Wockhardt EU Operations (Swiss) AG.

ANDA 088258

Thioridazine HCl Oral Solution USP (Concentrate), 30 mg/mL

Do.

ANDA 088270

Thioridazine HCl Tablets USP, 10 mg

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.

ANDA 088271

Thioridazine HCl Tablets USP, 15 mg

Do.

ANDA 088272

Thioridazine HCl Tablets USP, 25 mg

Do.

ANDA 088273

Thioridazine HCl Tablets USP, 100 mg

Do.

ANDA 088456

Thioridazine HCl Tablets USP, 100 mg

Teva Pharmaceuticals USA.

ANDA 088493

Thioridazine HCl Tablets USP, 10 mg

Do.

ANDA 088850

Hydroflumethiazide Tablets USP, 50 mg

Par Pharmaceutical, Inc.

ANDA 088907

Reserpine and Hydroflumethiazide Tablets, 0.125 mg/50 mg

Do.

ANDA 088933

Sulfinpyrazone Tablets, 100 mg

Do.

ANDA 088934

Sulfinpyrazone Capsules USP, 200 mg

Do.

ANDA 089135

Methyclothiazide Tablets, 2.5 mg

Do.

ANDA 089136

Methyclothiazide Tablets, 5 mg

Do.

ANDA 089173

A-MethaPred (methylprednisolone sodium succinate for injection USP), 500 mg (base)/Vial

Hospira, Inc.

ANDA 089174

A-MethaPred (methylprednisolone sodium succinate for injection USP), 1 gram (base)/Vial

Do.

ANDA 089207

Methylprednisolone Tablets USP, 16 mg

Par Pharmaceutical, Inc.

ANDA 089208

Methylprednisolone Tablets USP, 24 mg

Do.

ANDA 089209

Methylprednisolone Tablets USP, 32 mg

Do.

ANDA 089457

Perphenazine Tablets USP, 16 mg

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.

ANDA 089602

Thioridazine HCl Oral Solution USP, 30 mg/mL

Teva Pharmaceuticals USA.

ANDA 089603

Thioridazine HCl Oral Solution USP, 100 mg/mL

Do.

ANDA 089624

Reversol (edrophonium chloride injection USP), 10 mg/mL)

Organon USA Inc.

ANDA 089657

Methocarbamol and Aspirin Tablets, 400 mg/325 mg

Par Pharmaceutical, Inc.

ANDA 089708

Perphenazine Tablets USP, 4 mg

Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.

1

This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any albuterol or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December 7, 2006).

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective April 18, 2012. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 in this document that are in inventory on the date that this notice becomes effective (see the

DATES

section) 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 16, 2012.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am]

BILLING CODE 4160-01-P