Human drugs: Drug products withdrawn from sale for reasons other than safety or effectiveness Protamine sulfate injection, etc.,
[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Notices]
[Page 28982-28984]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my07-78]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0191]
Determination That Protamine Sulfate Injection and 26 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) has determined that the 27 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug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.
FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: 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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval
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of 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 Sec. 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.
Drug
Applicant
NDA 6-460
Protamine Sulfate
Eli Lilly and Co., Lilly Injection, 10 milligrams Corporate Center, (mg)/milliliter (mL) in a Indianapolis, IN 46285 25-mL vial
NDA 6-773
ARTANE (trihexyphenidyl Lederle, c/o Wyeth hydrochloride (HCl))
Pharmaceuticals, P.O. Box Tablets, 2 mg and 5 mg 8299, Philadelphia, PA 19101-8299
NDA 8-857
PHENERGAN (promethazine Wyeth Pharmaceuticals, HCl) Injection, 25 mg/mL P.O. Box 8299, and 50 mg/mL in 1-mL
Philadelphia, PA 19101- vials
8299
NDA 9-149
THORAZINE (chlorpromazine GlaxoSmithKline, 2301 HCl) Tablets, 10, 25, 50, Renaissance Blvd., King 100, and 200 mg
of Prussia, PA 19406
NDA 11-145
DIURIL (chlorothiazide) Merck & Co., Inc., Tablets, 250 mg and 500 Sumneytown Pike, BLA-20, mg
P.O. Box 4, West Point, PA 19486
NDA 11-664
DECADRON (dexamethasone) Do. Tablets, 0.25, 4, and 6 mg
NDA 11-808
MELLARIL (thioridazine Novartis Pharmaceuticals HCl) Tablets, 10, 15, 25, Corp., One Health Plaza, 50, 100, 150, and 200 mg East Hanover, NJ 07936
NDA 11-870
DIURIL (chlorothiazide) Merck & Co., Inc. Suspension, 250 mg/5 mL
NDA 13-400
ALDOMET (methyldopa)
Do. Tablets, 125, 250, and 500 mg
NDA 13-401
ALDOMET (methyldopate HCl) Do. Injection, 50 mg/mL
NDA 16-363
LASIX (furosemide)
Aventis Pharmaceuticals, Injection, 10 mg/mL
Inc., 200 Crossing Blvd., Bridgewater, NJ 08807- 0890
NDA 17-391
IMURAN (azathioprine) Prometheus Laboratories, Injection, 100 mg base/ 5739 Pacific Center vial
Blvd., San Diego, CA 92121-4203
NDA 17-939
TAGAMET (cimetidine HCl) GlaxoSmithKline Injection, 300 mg/2 mL
NDA 18-513
CHENIX (chenodiol)
Axcan Scandipharm, Inc., Tablets, 250 mg
22 Inverness Center Parkway, Birmingham, AL 35242-4814
NDA 18-675
TAVIST (clemastine
Novartis Consumer Health, fumarate) Oral Syrup, 0.5 Inc., 200 Kimball Dr., mg/5 mL
Parsippany, NJ 07054-0622
NDA 18-922
LODINE (etodolac)
Wyeth Pharmaceuticals, Capsules, 200 mg; LODINE Inc. Tablets, 400 mg and 500 mg
NDA 19-201
VOLTAREN (diclofenac
Novartis Pharmaceuticals, sodium) Delayed-Release Inc. Tablets, 25 mg and 50 mg
NDA 19-243
PROVENTIL (albuterol
Schering-Plough sulfate) Inhalation
Corporation, 2000 Solution, 0.5% and 0.083% Galloping Hill Rd., Kenilworth, NJ 07033
NDA 19-434
TAGAMET HCl (cimetidine GlaxoSmithKline HCl) in Sodium Chloride 0.9% in Plastic Container, EQ 6 mg/mL
NDA 19-471
CARDIZEM SR (diltiazem Biovail Laboratories, HCl) Capsules, 60, 90, Inc., c/o Bioavail 120, and 180 mg
Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807- 0980
NDA 19-817
PERSANTINE (dipyridamole) Boehringer Ingelheim Injection, 5 mg/mL
Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
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NDA 20-144
TRANSDERM-NITRO
Novartis Pharmaceuticals (nitroglycerin), 0.1 mg/ Corp. hour (hr), 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hr
NDA 20-584
LODINE (etodolac) XL
Wyeth Pharmaceuticals, Tablets, 600 mg
Inc.
NDA 21-110
RAPAMUNE (sirolimus)
Wyeth Pharmaceuticals, Tablets, 5 mg
Inc.
NDA 50-477
NEBCIN (tobramycin
Eli Lilly and Co. sulfate) Injection, 10 mg/ mL
NDA 50-519
NEBCIN (tobramycin
Do. sulfate) Injection, 1.2 grams/vial
ANDA 62-008 NEBCIN (tobramycin
Do. sulfate) Injection, 40 mg/ mL
FDA has reviewed its records and, under Sec. 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.
Dated: May 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy.
[FR Doc. E7-9962 Filed 5-22-07; 8:45 am]
BILLING CODE 4160-01-S
