Determination That PRO-BANTHINE (Propantheline Bromide) Tablets and 14 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 15 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
For further information contact:
Olivia Pritzlaff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6308, Silver Spring, MD 20993-0002, 301-796-3601.
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 Under FDA regulations, a drug is withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved; (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved; and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, 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 applicant, FDA withdrew approval of NDA 12-097 for KENALOG IN ORABASE (triamcinolone acetonide) Dental Paste in the Federal Register of February 11, 2009 (74 FR 6896).)
|NDA 8-732||PRO-BANTHINE (propantheline bromide) Tablets, 7.5 milligrams (mg) and 15 mg||Shire Pharmaceuticals, Inc.,725 Chesterbrook Blvd., Wayne, PA 19087)|
|NDA 12-097||KENALOG IN ORABASE (triamcinolone acetonide) Dental Paste, 0.1%||Apothecon, Inc., c/o Bristol-Myers Squibb, P.O. Box 4500, Princeton, NJ 08543-4500|
|NDA 12-141||CYTOXAN (cyclophosphamide) Tablets, 25 mg and 50 mg||Baxter Healthcare Corp., 1620 Waukegan Rd. MPGR-AL, McGaw Park, IL 60085|
|NDA 17-498||MICRONASE (glyburide) Tablets, 1.25 mg, 2.5 mg, and 5 mg||Pharmacia and Upjohn Co., 7171 Portage Rd., Kalamazoo, MI 49001|
|NDA 17-924||TAGAMET (cimetidine HCl) Oral Solution, Equivalent to (EQ) 300 mg base/5 mL||GlaxoSmithKline, 5 Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709-3398|
|NDA 18-207||DESYREL (trazodone HCl) Tablets, 50 mg, 100 mg, 150 mg, and 300 mg||Apothecon, Inc.|
|NDA 19-425||TRANDATE (labetalol HCl) Injection, 5 mg/mL||Prometheus Laboratories, Inc., 9410 Carroll Park Dr., San Diego, CA 92121|
|NDA 20-101||PROZAC (fluoxetine HCl) Oral Solution, EQ 20 mg base/5 mL||Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285|
|NDA 20-286||MONOPRIL-HCT (fosinopril sodium; hydrochlorothiazide) Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg||Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000|
|NDA 20-664||DOSTINEX (cabergoline) Tablet, 0.5 mg||Pharmacia and Upjohn Co.|
|NDA 20-683||ALESSE (ethinyl estradiol; levonorgestrel) Tablets (21 Tablets and 28 Tablets), 0.02 mg; 0.1 mg||Wyeth Pharmaceuticals Inc., P.O. Box 8299, Philadelphia, PA 19101-8299|
|NDA 20-801||PEPCID AC (famotidine) Chewable Tablet, 10 mg||Merck Research Laboratories, Sumneytown Pike BLA 20, P.O. Box 4, West Point, PA 19486-0004|
|NDA 20-860||LEVLITE (ethinyl estradiol; levonorgestrel) Tablets (21 Tablets and 28 Tablets), 0.02 mg; 0.1 mg||Bayer Healthcare Pharmaceuticals, Inc., 340 Changebridge Rd., P.O. Box 1000, Montville, NJ 07045-1000|
|NDA 21-455||BONIVA (ibandronate sodium) Tablet, EQ 2.5 mg base||Hoffmann LaRoche, Inc., 340 Kingsland St., Bldg. 719/4, Nutley, NJ 07110-1199|
|NDA 50-517||MEFOXIN (cefoxitin sodium) Injection, EQ 1 gram (g) base/vial and EQ 2 g base/vial||Merck and Co., Inc., Sumneytown Pike BLA 20, P.O. Box 4, West Point, PA 19486-0004|
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 listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these 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: March 8, 2010. Leslie Kux, Acting Assistant Commissioner for Policy.