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Determination That Ranitidine Effervescent 75-Milligram Tablet Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing its determination that ranitidine effervescent 75-milligram (mg) tablet (Zantac Efferdose) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for ranitidine effervescent 75-mg tablet.

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Andrea C. Masciale, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the 1984 amendments) (Public Law 98-417), 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 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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Regulations also provide that the agency must make a determination as to whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug.

Ranitidine effervescent 75-mg tablet is the subject of NDA 20-745. FDA approved NDA 20-745, held by Glaxo Wellcome, Inc. (Glaxo), on February 26, 1998. Glaxo never marketed the ranitidine effervescent 75-mg tablet. Glaxo transferred ownership of NDA 20-745 to the Warner-Lambert Co. (Warner-Lambert) effective January 1, 1999. To date, Warner-Lambert has not marketed the ranitidine effervescent 75-mg tablet.

On March 1, 2000, Thomas Blake, R.Ph., submitted a citizen petition (Docket No. 00P-0842/CP1) under 21 CFR 10.30 to FDA. The petition requested that the agency determine whether ranitidine effervescent 75-mg tablet was withdrawn from sale for reasons of safety or effectiveness. FDA has determined that, for the purposes of § 314.161, never marketing an approved drug product is equivalent to withdrawing the drug product from sale.

FDA has reviewed its records and, under § 314.161, has determined that the decision by Glaxo and Warner-Lambert not to market ranitidine effervescent 75-mg tablet was not for reasons of safety or effectiveness. Accordingly, the agency will maintain ranitidine effervescent 75-mg tablet 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 ranitidine effervescent 75-mg tablet may be approved by the agency.

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Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 00-15555 Filed 6-20-00; 8:45 am]