Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) has determined that PHENERGAN (promethazine hydrochloride (HCl)) suppositories, 12.5 milligrams (mg) and 25 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for promethazine HCl suppositories, 12.5 mg and 25 mg.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.End Further Info End Preamble Start Supplemental 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 (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 removed from the list if the agency withdraws or suspends approval of the drug's NDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.
PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, are the subject of approved NDA 10-926 held by Wyeth Pharmaceuticals, Inc. (Wyeth). PHENERGAN (promethazine HCl) suppositories are indicated for, among other things, certain types of allergic reactions and sedation. Wyeth's NDA 10-926 was originally approved in 1958. In 1971, under the Drug Efficacy Study Implementation (DESI), FDA concluded that promethazine HCl rectal suppositories were effective or probably effective for the indications described in the Federal Register notice published on June 18, 1971 (DESI 6290, 36 FR 11758). In a citizen petition received November 1, 2006 (Docket No. 2006P-0446/CP1), submitted under 21 CFR 10.30, Taro Pharmaceuticals U.S.A., Inc., requested that the agency determine, as described in § 314.161, whether PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, were withdrawn from sale for reasons of safety or effectiveness.
The agency has determined that PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, were not withdrawn from sale for reasons of safety or effectiveness. In support of this finding, we note that promethazine HCl is a widely used product that has been marketed for many decades in many dosage forms. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that PHENERGAN Start Printed Page 43645suppositories, 12.5 mg and 25 mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing its records, FDA determines that, for the reasons outlined in this notice, PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to PHENERGAN (promethazine HCl) suppositories, 12.5 mg and 25 mg, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. 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.Start Signature
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15174 Filed 8-3-07; 8:45 am]
BILLING CODE 4160-01-S