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Determination That Protamine Sulfate Injection and 26 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) has determined that the 27 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) for the drug products, and it will allow FDA to continue to approve ANDAs for the products.

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Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20855, 301-594-2041.

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In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval Start Printed Page 28983of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved or (2) whenever a listed drug is voluntarily withdrawn from sale, and ANDAs that refer to the listed drug have been approved. Section 314.161(d) provides that if FDA determines that a listed drug was removed from sale for safety or effectiveness reasons, the agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

FDA has become aware that the drug products listed in the table in this document are no longer being marketed. (As requested by the applicants, FDA withdrew approval of NDA 6-460 for Protamine Sulfate Injection, NDA 18-675 for TAVIST Syrup, NDA 19-243 for PROVENTIL Inhalation Solution, NDA 19-471 for CARDIZEM SR Capsules, and NDA 19-817 for PERSANTINE Injection in the Federal Register of March 4, 2005 (70 FR 10651), NDA 8-857 for PHENERGAN Injection in the Federal Register of May 5, 2004 (69 FR 25124), and NDA 13-400 for ALDOMET Tablets and NDA 13-401 for ALDOMET Injection in the Federal Register of June 16, 2006 (71 FR 34940)).

Application No.DrugApplicant
NDA 6-460Protamine Sulfate Injection, 10 milligrams (mg)/milliliter (mL) in a 25-mL vialEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 6-773ARTANE (trihexyphenidyl hydrochloride (HCl)) Tablets, 2 mg and 5 mgLederle, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 8-857PHENERGAN (promethazine HCl) Injection, 25 mg/mL and 50 mg/mL in 1-mL vialsWyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 9-149THORAZINE (chlorpromazine HCl) Tablets, 10, 25, 50, 100, and 200 mgGlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA 19406
NDA 11-145DIURIL (chlorothiazide) Tablets, 250 mg and 500 mgMerck & Co., Inc., Sumneytown Pike, BLA-20, P.O. Box 4, West Point, PA 19486
NDA 11-664DECADRON (dexamethasone) Tablets, 0.25, 4, and 6 mgDo.
NDA 11-808MELLARIL (thioridazine HCl) Tablets, 10, 15, 25, 50, 100, 150, and 200 mgNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936
NDA 11-870DIURIL (chlorothiazide) Suspension, 250 mg/5 mLMerck & Co., Inc.
NDA 13-400ALDOMET (methyldopa) Tablets, 125, 250, and 500 mgDo.
NDA 13-401ALDOMET (methyldopate HCl) Injection, 50 mg/mLDo.
NDA 16-363LASIX (furosemide) Injection, 10 mg/mLAventis Pharmaceuticals, Inc., 200 Crossing Blvd., Bridgewater, NJ 08807-0890
NDA 17-391IMURAN (azathioprine) Injection, 100 mg base/vialPrometheus Laboratories, 5739 Pacific Center Blvd., San Diego, CA 92121-4203
NDA 17-939TAGAMET (cimetidine HCl) Injection, 300 mg/2 mLGlaxoSmithKline
NDA 18-513CHENIX (chenodiol) Tablets, 250 mgAxcan Scandipharm, Inc., 22 Inverness Center Parkway, Birmingham, AL 35242-4814
NDA 18-675TAVIST (clemastine fumarate) Oral Syrup, 0.5 mg/5 mLNovartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054-0622
NDA 18-922LODINE (etodolac) Capsules, 200 mg; LODINE Tablets, 400 mg and 500 mgWyeth Pharmaceuticals, Inc.
NDA 19-201VOLTAREN (diclofenac sodium) Delayed-Release Tablets, 25 mg and 50 mgNovartis Pharmaceuticals, Inc.
NDA 19-243PROVENTIL (albuterol sulfate) Inhalation Solution, 0.5% and 0.083%Schering-Plough Corporation, 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 19-434TAGAMET HCl (cimetidine HCl) in Sodium Chloride 0.9% in Plastic Container, EQ 6 mg/mLGlaxoSmithKline
NDA 19-471CARDIZEM SR (diltiazem HCl) Capsules, 60, 90, 120, and 180 mgBiovail Laboratories, Inc., c/o Bioavail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807-0980
NDA 19-817PERSANTINE (dipyridamole) Injection, 5 mg/mLBoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
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NDA 20-144TRANSDERM-NITRO (nitroglycerin), 0.1 mg/hour (hr), 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hrNovartis Pharmaceuticals Corp.
NDA 20-584LODINE (etodolac) XL Tablets, 600 mgWyeth Pharmaceuticals, Inc.
NDA 21-110RAPAMUNE (sirolimus) Tablets, 5 mgWyeth Pharmaceuticals, Inc.
NDA 50-477NEBCIN (tobramycin sulfate) Injection, 10 mg/mLEli Lilly and Co.
NDA 50-519NEBCIN (tobramycin sulfate) Injection, 1.2 grams/vialDo.
ANDA 62-008NEBCIN (tobramycin sulfate) Injection, 40 mg/mLDo.

FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDA listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDA. Additional ANDAs for the products may also be approved by the agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.

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Dated: May 15, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-9962 Filed 5-22-07; 8:45 am]