# Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3AE7-21886

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** November 7, 2007
- **Citation:** 72 FR 62858

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0427]
Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 73 new drug applications (NDAs) and 62 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

EFFECTIVE DATE
: December 7, 2007.

FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing.

Application No.
Drug
Applicant

NDA 6-459
Hetrazan (diethylcarbamaxine citrate) Tablets and Syrup
Lederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299

NDA 6-799
Rubramin and Rubramin PC (cyanocobalamin injection USP)
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000

NDA 7-517
Tapazole (methimazole tablets USP), 5 milligrams (mg) and 10 mg
King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620

NDA 7-942
Sus-Phrine (epinephrine) Injection
Forest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311

NDA 9-319
Ambenyl Expectorant and Ambenyl Cough Syrup
Do.

NDA l0-533
PBZ SR (tripelennamine HCl USP) Extended-Release Tablets
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080

NDA 10-744
Darbid (isopropamide iodide) Tablets
SmithKline Beecham Corp., d/b/a/ GlaxoSmith Kline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709

NDA 10-909
Miradon (anisindione) Tablets
Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033

NDA 11-213
Trilafon (perphenazine) Injection, 5 mg/milliliter (mL)
Do.

NDA 11-283
Kenacort (tramcinolone) Tablets
Bristol-Myers Squibb Co.

NDA 11-808
Mellaril (thioridazine HCl) Tablets
Novartis Pharmaceuticals Corp.

NDA 12-145
Prolixin (fluphenazine HCl) Elixir, 0.5 mg/mL
Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500

NDA 12-313
BIO-CLEAR (dibenzothiophene) Cream
Helena Rubinstein, 202 Rodney Bldg., 3411 Silverside Rd., Wilmington, DE 19810

NDA 12-665
Velban (vinblastine sulfate) for Injection
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285

NDA 12-678
Tolbutamide Tablets
Sandoz Inc., 227-15 North Conduit Ave., Laurelton, NY 11413

NDA 12-796
Quinidex Extentabs (quinidine sulfate extended-release tablets USP)
Wyeth Pharmaceuticals, Inc.

NDA 14-103
Oncovin (vincristine sulfate) Injection
Eli Lilly and Co.

NDA 14-242
Dexacort (dexamethasone sodium phosphate) Turbinaire
UCB, 755 Jefferson Rd., Rochester, NY 14623

NDA 14-262
Solbar (dioxybenzone and oxybenzone) Cream
Person & Covey, Inc., 616 Allen Ave., Glendale, CA 91201

NDA 16-363
Lasix (furosemide) 10-mg/mL Injection
Sanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977

NDA 16-408
WILDROOT (pyrithione zinc) Hair Groom and Grenadier Hair Groom
Colgate-Palmolive Co., 909 River Rd., Piscataway, NJ 08854-5596

NDA 16-729
Ferrous Citrate Fe 59 Injection
Mallinckrodt Inc., 675 McDowell Blvd., P.O. Box 5840, St. Louis, MO 63134

NDA 16-820
Emete-Con (benzquinamide HCl) Injection
Pfizer, Inc., 235 East 42nd St., New York, NY 10017

NDA 16-847
Isopaque 440 (metrizoate sodium, meglumine metrizoate, calcium metrizoate, and metrizoate magnesium) Injection
GE Healthcare, 101 Carnegie Center, Princeton, NJ 08540

NDA 17-430
Neggram (nalidixic acid USP) Suspension
Sanofi-Aventis

NDA 17-466
Bricanyl (terbutaline sulfate) Injection
Sanofi-Aventis

NDA 17-506
Isopaque 280 (metrizoic acid, meglumine, and calcium) Injection
GE Healthcare

NDA 17-613
Lotrimin (clotrimazole) Topical Solution, 1%
Schering Corp.

NDA 17-618
Bricanyl (terbutaline sulfate) Tablets
Sanofi-Aventis

NDA 17-619
Lotrimin (clotrimazole) Cream, 1%
Schering Corp.

NDA 17-668
Tenuate (diethylpropion HCl) Tablets, 25 mg
Sanofi-Aventis

NDA 17-669
Tenuate (diethylpropion HCl) Extended-Release Tablets, 75 mg
Sanofi-Aventis

NDA 17-688
Lasix (furosemide) Oral Solution, 10 mg/mL
Sanofi-Aventis

NDA 17-719
Dimeray (iocarmate meglumine) Injection
Mallinckrodt Inc.

NDA 17-725
Sodium Pertechnetate Tc-99m (technectium Tc-99m sodium pertechnetate)
Mallinckrodt Inc.

NDA 17-730
Isopaque 370 (metrizoic acid and meglume) Injection
GE Healthcare

NDA 17-769
Calcimar (calcitonin salmon) Injection
Sanofi-Aventis

NDA 17-838
Lungaggregate Reagent
GE Healthcare

NDA 17-848
Tc-99m Lungaggregate
Do.

NDA 17-907
Glucoscan Kit for the Preparation of Technetium Tc-99m Gluceptate
Bristol-Myers Squibb Pharma Co., Chestnut Run Plaza, 974 Centre Rd., Wilmington, DE 19805

NDA 17-923
Mellaril-S (thioridazine HCl) Oral Suspension
Novartis Pharmaceuticals Corp.

NDA 17-956
Tepanil (diethylpropion HCl) Ten-Tabs
3M Pharmaceuticals, 3M Center, Bldg 0275-05-W-12, St. Paul, MN 55144-1000

NDA 18-000
Bricanyl (terbutaline sulfate) Inhaler
Sanofi-Aventis

NDA 18-067
Cinobac (cinoxacin) Capsules, 250 mg and 500 mg
Eli Lilly and Co.

NDA 18-088
Krypton Kr-81m Gas Generator
GE Healthcare

NDA 18-148
Nasalide (flunisolide) Nasal Spray
IVAX Research, Inc., 4400 Biscayne Blvd., Miami, FL 33137

NDA 18-489
Technescan HIDA (kit for the preparation of technetium Tc-99m lidofenin injection)
Draximage, 16751 Autoroute TransCanada Highway, Kirkland, Quebec, H9H 4J4, Canada

NDA 18-519
Irrigation Solution G (citric acid and sodium carbonate)
Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085

NDA 18-554
Eulexin (flutamide) Capsules
Schering Corp.

NDA 18-700
Inocor (inamrinone lactate) Injection, 5 mg base/mL
Sanofi-Synthelabo Inc., c/o Sanofi-Aventis, 300 Somerset Corporate Blvd., P.O. Box 6977, Bridgewater, NJ 08807-0977

NDA 18-770
Tornalate (bitolterol mesylate) Metered-Dose Inhaler
Sanofi-Aventis

NDA 18-813
Lotrimin (clotrimazole) Lotion, 1%
Schering Corp.

ANDA 18-862
Betatrex (betamethasone valerate cream USP, 0.1%)
Savage Laboratories, 60 Baylis Rd., Melville, NY 11747

ANDA 18-863
Betatrex (betamethasone valerate ointment USP, 0.1%)
Do.

ANDA 18-867
Betatrex (betamethasone valerate lotion USP, 0.1%)
Do.

NDA 19-084
Nizoral (ketoconazole) Cream, 2%
Johnson & Johnson Pharmaceutical Research & Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560

NDA 19-284
Oral Colonic Lavage (OCL) (sodium chloride, sodium bicarbonate, sodium sulfate, potassium chloride, and polyethelene glycol 3350)
Hospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, Il 60045-5046

NDA 19-408
Diprolene (betamethasone dipropionate)
Schering Corp.

NDA 19-459
Photoplex (7% padimate O and 3% avobenzone) Lotion
Allergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534

NDA 19-520
Travasol (amino acid) in Dextrose Injection
Baxter Healthcare Corp.

NDA 19-545
Didronel (etidronate disodium) Injection
MGI Pharma, Inc., 5775 West Old Shakopee Rd., suite 100, Bloomington, MN 55437-3174

NDA 19-548
Tornalate (bitolterol mesylate) Inhalatioon Solution, 0.2%
Sanofi-Aventis

NDA 19-576
Nizoral (ketoconazole) Cream, 2%
Johnson & Johnson Pharmaceutical & Development, LLC

NDA 19-648
Nizoral (ketoconazole) Cream, 2%
Do.

NDA 20-091
Imagent (perflubron)
Alliance Pharmaceuticals Corp., 4660 La Jolla Dr., suite 740, San Diego, CA 92122

NDA 20-147
Travasol (amino acid) with Electrolytes in Dextrose Injection
Baxter Healthcare Corp.

NDA 20-228
Atrovent (ipratropium bromide) Inhalation Solution
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368

NDA 20-303
Prempro/Premphase (conjugated estrogens and medroxyprogesterone acetate) Tablets
Wyeth Pharmaceuticals, Inc.

NDA 20-315
Orlaam (levomethadyl acetate HCl) Oral Solution
Roxane Laboratories, P.O. Box 16532, Columbus, OH 43216-6532

NDA 20-486
Vanceril (beclomethasone dipropionate) Double Strength Aerosol
Schering Corp.

NDA 20-887
AcuTect Kit for the Preparation of Technetium Tc-99m Apticide Injection
CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730

NDA 21-012
Neo-Tect Kit for the Preparation of Technetium Tc-99m Depreotide Injection
Do.

NDA 21-075
Nutropin Depot (somatropin recombinant)
Genentech Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990

ANDA 40-098
Acetaminophen and Codeine Phosphate Oral Solution USP
Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512

NDA 50-477
Nebcin (tobramycin sulfate) for Injection
Eli Lilly and Co.

NDA 50-519
Nebcin (tobramycin sulfate) for Injection
Do.

NDA 50-678
Dynabac (dirithromycin delayed-release tablets USP)
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285

ANDA 60-212
Grisactin (griseofulvin microcrystalline) Tablets, 500 mg
Wyeth Ayerst Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101

ANDA 60-570
Fungizone (amphotericin B lotion USP), 3%
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 60-751
NEO-CORTEF (neomycin sulfate and hydrocortisone acetate) Ointment
Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017

ANDA 61-007
Terramycin (oxytetracycline HCl, polymyxin B sulfate) Topical Ointment with Polymyxin B Sulfate
Pfizer, Inc.

ANDA 61-131
Nystatin Powder USP
Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.

ANDA 61-411
Veetids (penicillin V potassium tablets USP), 250 mg and 500 mg
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 61-737
ZIBA-Rx (bacitracin zinc USP)
X-GEN Pharmaceuticals, Inc., P.O. Box 1148, Elmira, NY 14902

ANDA 61-859
Anspor (cephradine) Capsules, 250 mg and 500 mg
GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929

ANDA 61-866
Anspor (cephradine) for Oral Suspension
Do.

ANDA 61-876
Cerubidine Injection (daunorubice HCl for injection USP)
Sanofi-Aventis

ANDA 62-519
Nystex (nystatin) Oral Suspension USP, 100,000 units/mL
Savage Laboratories

ANDA 62-560
Mandol (cefamadole nafate for injection USP)
Eli Lilly and Co.

ANDA 62-739
Tazidime (ceftazidime)
Do.

ANDA 62-745
Cephalexin Tablets USP
Do.

ANDA 62-888
Principen (ampicillin capsules USP), 250 mg and 500 mg
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 62-926
Rubex (doxorubicin HCl for injection USP)
Bristol-Myers Squibb Co.

ANDA 63-021
Kanamycin Sulfate Injection USP, 75 mg/2 mL
Loch Pharmaceuticals, c/o Bedford Laboratories, A Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146

ANDA 63-022
Kanamycin Sulfate Injection USP, 500 mg/2 mL
Do.

ANDA 63-025
Kanamycin Sulfate Injection USP, 1 gram (g)/3 mL
Do.

ANDA 63-099
Trimox (amoxicillin capsules USP), 250 mg and 500 mg
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 70-867
Vincrex (vincristine sulfate for injection USP), 5 mg/vial
Bristol-Myers Squibb Co.

ANDA 71-742
Clorazepate Dipotassium Capsules, 3.75 mg
Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.

ANDA 71-743
Clorazepate Dipotassium Capsules, 7.5 mg
Do.

ANDA 71-744
Clorazepate Dipotassium Capsules, 15 mg
Do.

ANDA 72-326
Fenoprofen Calcium Tablets USP, 600 mg
Do.

ANDA 72-507
Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg
Do.

ANDA 72-508
Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg
Do.

ANDA 72-509
Methyldopa and Hydrochlorothiazide Tables USP, 500 mg/30 mg
Do.

ANDA 72-510
Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg
Do.

ANDA 72-705
Prazosin HCl Capsules USP, 1 mg
Do.

ANDA 72-706
Prazosin HCl Capsules USP, 2 mg
Do.

ANDA 72-707
Prazosin HCL Capsules USP, 5 mg
Do.

ANDA 74-258
Metoprolol Tartrate Tablets USP, 50 mg and 100 mg
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 74-423
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg
Clonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc.

ANDA 74-472
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg
Apothecon, c/o Bristol-Myers Squibb Co.

ANDA 75-407
Morphine Sulfate Extended-Release Tablets USP, 15 mg
Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.

ANDA 80-745
Aristocort (triamcinolone acetonide) Ointment, 0.5%
Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537

ANDA 80-750
Aristocort (triamcinolone acetonide) Ointment, 0.1%
Do.

ANDA 83-015
Aristocort (triamcinolone acetonide) Cream, 0.5%
Do.

ANDA 83-016
Aristocort (triamcinolone acetonide) Cream, 0.1%
Do.

ANDA 83-017
Aristocort (triamcinolone acetonide) Cream, 0.025%
Do.

ANDA 83-149
PBZ (tripelennamine HCl) Tablet, 25 mg
Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080

ANDA 83-317
Propoxyphene HCl Capsules, 65 mg
Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544

ANDA 83-380
Aristogel (triamcinolone acetonide) Gel, 0.1%
Astellas Pharma US, Inc.

ANDA 83-881
Aristocort A (triamcinolone acetonide) Spray
Do.

ANDA 86-212
Chlordiazepoxide HCl Capsules, 25 mg
Impax Laboratories, Inc.

ANDA 86-213
Chlordiazepoxide Capsules, 5 mg
Do.

ANDA 86-358
Mexate (methotrexate sodium for injection)
Bristol-Myers Squibb Co.

ANDA 86-926
Tolbutamide Tablets USP, 500 mg
Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.

ANDA 87-011
Quinidine Sulfate Tablets USP, 200 mg
Do.

ANDA 87-677
Hydrocodone Bitartrate and Acetaminophen
B.F. Ascher & Co., Inc., 15501 West 109th St., Lenexa, KS 66219

ANDA 87-887
TRYSUL (triple sulfa vaginal cream USP)
Savage Laboratories

ANDA 88-584
DHC Plus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules
The Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431

ANDA 88-760
Mexate-AQ (methotrexate sodium injection USP), 25 mg
Bristol-Myers Squibb Co.

ANDA 88-780
Aristocort A Ointment (triamcinolone acetonide ointment USP), 0.1%
Astellas Pharma US, Inc.

ANDA 88-781
Aristocort A (triamcinolone acetonide) Ointment, 0.5%
Do.

ANDA 88-944
Sedapap (butalbital and acetaminophen) Tablets, 50 mg/650 mg
Merz Pharmaceuticals, LLC, 4215 Tudor Lane, Greensboro, NC 27410

ANDA 89-887
Mexate-AQ Preserved (methotrexate sodium injection USP), 25 mg/mL
Bristol-Myers Squibb Co.

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic 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 the table in this document, and all amendments and

supplements thereto, is hereby withdrawn, effective December 7, 2007.

Dated: October 26, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.

[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE7-21886. Public record. Not legal advice.