[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)] [Notices] [Pages 3903-3904] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-1849] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 96P-0316] Determination That Minocycline Hydrochloride Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) has determined that minocycline hydrochloride tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for minocycline hydrochloride tablets. FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 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 under a new drug application (NDA). Sponsors of ANDA's do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an 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 included what is now section 505(j)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(6)), 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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Regulations also provide that the agency must make a determination as to [[Page 3904]] 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 (Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)). FDA may not approve an ANDA that does not refer to a listed drug. In a citizen petition dated August 26, 1996 (Docket No. 96P-0316/ CP), submitted in accordance with 21 CFR 314.122, Clausen & Associates, Inc., requested that the agency determine whether minocycline hydrochloride tablets were withdrawn from sale for reasons of safety or effectiveness. Minocycline hydrochloride (Minocin) tablets are the subject of approved NDA 50-451 held by Lederle Laboratories. In 1996, Lederle withdrew minocycline hydrochloride tablets from sale. FDA has reviewed its records and, under Sec. 314.161, has determined that minocycline hydrochloride tablets were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will maintain minocycline hydrochloride tablets 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. ANDA's that refer to minocycline hydrochloride tablets may be approved by the agency. Dated: January 20, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-1849 Filed 1-26-98; 8:45 am] BILLING CODE 4160-01-F