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 Department of Health and Human Services Food and Drug Administration [Docket No. 2007N-0191]
 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The Food and Drug Administration (FDA) has determined that the 27 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval 
                    ( print page 28983)
                    of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved or (2) whenever a listed drug is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
ApplicantNDA 6-460
Protamine Sulfate Injection, 10 milligrams (mg)/milliliter (mL) in a 25-mL vial
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285NDA 6-773
ARTANE (trihexyphenidyl hydrochloride (HCl)) Tablets, 2 mg and 5 mg
Lederle, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299NDA 8-857
PHENERGAN (promethazine HCl) Injection, 25 mg/mL and 50 mg/mL in 1-mL vials
Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299NDA 9-149
THORAZINE (chlorpromazine HCl) Tablets, 10, 25, 50, 100, and 200 mg
GlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA 19406NDA 11-145
DIURIL (chlorothiazide) Tablets, 250 mg and 500 mg
Merck & Co., Inc., Sumneytown Pike, BLA-20, P.O. Box 4, West Point, PA 19486NDA 11-664
DECADRON (dexamethasone) Tablets, 0.25, 4, and 6 mg
Do.NDA 11-808
MELLARIL (thioridazine HCl) Tablets, 10, 15, 25, 50, 100, 150, and 200 mg
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936NDA 11-870
DIURIL (chlorothiazide) Suspension, 250 mg/5 mL
Merck & Co., Inc.NDA 13-400
ALDOMET (methyldopa) Tablets, 125, 250, and 500 mg
Do.NDA 13-401
ALDOMET (methyldopate HCl) Injection, 50 mg/mL
Do.NDA 16-363
LASIX (furosemide) Injection, 10 mg/mL
Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., Bridgewater, NJ 08807-0890NDA 17-391
IMURAN (azathioprine) Injection, 100 mg base/vial
Prometheus Laboratories, 5739 Pacific Center Blvd., San Diego, CA 92121-4203NDA 17-939
TAGAMET (cimetidine HCl) Injection, 300 mg/2 mL
GlaxoSmithKlineNDA 18-513
CHENIX (chenodiol) Tablets, 250 mg
Axcan Scandipharm, Inc., 22 Inverness Center Parkway, Birmingham, AL 35242-4814NDA 18-675
TAVIST (clemastine fumarate) Oral Syrup, 0.5 mg/5 mL
Novartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054-0622NDA 18-922
LODINE (etodolac) Capsules, 200 mg; LODINE Tablets, 400 mg and 500 mg
Wyeth Pharmaceuticals, Inc.NDA 19-201
VOLTAREN (diclofenac sodium) Delayed-Release Tablets, 25 mg and 50 mg
Novartis Pharmaceuticals, Inc.NDA 19-243
PROVENTIL (albuterol sulfate) Inhalation Solution, 0.5% and 0.083%
Schering-Plough Corporation, 2000 Galloping Hill Rd., Kenilworth, NJ 07033NDA 19-434
TAGAMET HCl (cimetidine HCl) in Sodium Chloride 0.9% in Plastic Container, EQ 6 mg/mL
GlaxoSmithKlineNDA 19-471
CARDIZEM SR (diltiazem HCl) Capsules, 60, 90, 120, and 180 mg
Biovail Laboratories, Inc., c/o Bioavail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807-0980NDA 19-817
PERSANTINE (dipyridamole) Injection, 5 mg/mL
Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368( print page 28984)NDA 20-144
TRANSDERM-NITRO (nitroglycerin), 0.1 mg/hour (hr), 0.2 mg/hr, 
                             0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hr
Novartis Pharmaceuticals Corp.NDA 20-584
LODINE (etodolac) XL Tablets, 600 mg
Wyeth Pharmaceuticals, Inc.NDA 21-110
RAPAMUNE (sirolimus) Tablets, 5 mg
Wyeth Pharmaceuticals, Inc.NDA 50-477
NEBCIN (tobramycin sulfate) Injection, 10 mg/mL
Eli Lilly and Co.NDA 50-519
NEBCIN (tobramycin sulfate) Injection, 1.2 grams/vial
Do.ANDA 62-008
NEBCIN (tobramycin sulfate) Injection, 40 mg/mL
Do.
 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. 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