Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) has determined that ACIPHEX (rabeprazole sodium) delayed-release tablets, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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 rabeprazole sodium delayed-release tablets, 10 mg.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, 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 typically 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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)).
Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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.
ACIPHEX delayed-release tablets are the subject of approved NDA 20-973 held by Eisai, Inc. (Eisai). ACIPHEX (rabeprazole sodium) delayed-release tablets are a proton pump inhibitor indicated for the healing of erosive or ulcerative gastroesophageal reflux disease (GERD), maintenance of healing of erosive GERD, healing of duodenal ulcers, and treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. Lachman Consultant Services, Inc., submitted a citizen petition dated July 6, 2004 (Docket No. 2004P-0285/CP1), under 21 CFR 10.30, requesting that the agency determine whether ACIPHEX delayed-release tablets, 10 mg, were withdrawn from sale for reasons of safety or effectiveness.
The agency has determined that Eisai's ACIPHEX delayed-release tablets, 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. ACIPHEX delayed-release tablets, 10 mg, were approved on May 29, 2002, and Eisai has never commercially marketed the 10-mg dose. In previous instances (see the Federal Register of December 30, 2002 (67 FR 79640 at 79641) (addressing a relisting request for Diazepam Autoinjector)), FDA has concluded that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. There is no indication that Eisai's decision not to market ACIPHEX delayed-release tablets, 10 mg, commercially is a function of safety or effectiveness concerns, and the petitioner has identified no data or other information suggesting that ACIPHEX delayed-release tablets, 10 mg, pose a safety risk. FDA's independent evaluation of relevant information has uncovered nothing that would indicate that this product was withdrawn for reasons of safety or effectiveness.
After considering the citizen petition and reviewing agency records, FDA determines that for the reasons outlined previously, ACIPHEX delayed-release tablets, 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list ACIPHEX (rabeprazole sodium) delayed-release tablets, 10 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 ACIPHEX delayed-Start Printed Page 15633release tablets, 10 mg, may be approved by the agency.Start Signature
Dated: March 17, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-5975 Filed 3-25-05; 8:45 am]
BILLING CODE 4160-01-S