[Federal Register: August 7, 1998 (Volume 63, Number 152)] [Notices] [Page 42406-42407] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07au98-120] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98P-0220] Determination That Acyclovir 200-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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Food and Drug Administration (FDA) is announcing its determination that acyclovir 200-milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness.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 acyclovir 200-mg tablets. FOR FURTHER INFORMATION CONTACT: Richard L. Schwartzbard, 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,'' a publication generally known as the ``Orange Book.'' Under the FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 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 September 17, 1997 (Docket No. 98P- 0220/CP1), received by FDA on April 1, 1998, and submitted in accordance with 21 CFR 314.122, TorPharm Inc., requested that the agency determine whether acyclovir 200-mg tablets were withdrawn from sale for reasons of safety or effectiveness. Acyclovir 200-mg tablets are the subject of approved ANDA 74- [[Page 42407]] 556 held by Novopharm Ltd.\1\ FDA approved ANDA 74-556 on April 22, 1997, and subsequently declared that Novopharm's acyclovir 200-mg tablets are a reference listed drug. However, after learning that Novopharm decided not to market ANDA 74-556, FDA moved the listing for acyclovir 200-mg tablets to the ``Discontinued Drug Product List'' section of the Orange Book. --------------------------------------------------------------------------- \1\ The reference listed drug upon which ANDA 74-556 itself was approved was Zovirax (acyclovir) 200-mg capsules. --------------------------------------------------------------------------- FDA has reviewed its records and, under Sec. 314.161, has determined that Novopharm's decision not to market its approved ANDA for acyclovir 200-mg tablets was not for reasons of safety or effectiveness. Accordingly, the agency will maintain acyclovir 200-mg tablets 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. ANDA's that refer to acyclovir 200-mg tablets may be approved by the agency. Dated: July 31, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-21129 Filed 8-6-98; 8:45 am] BILLING CODE 4160-01-F