[Federal Register Volume 70, Number 58 (Monday, March 28, 2005)]
[Notices]
[Pages 15632-15633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004P-0285]


Determination That ACIPHEX (Rabeprazole Sodium) Delayed-Release 
Tablets, 10 Milligrams, Were Not Withdrawn From Sale for Reasons of 
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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(mg), were not withdrawn from sale for reasons of safety or 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.

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.

SUPPLEMENTARY 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 Under FDA regulations, drugs are withdrawn from the list if the 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 (Sec.  314.162 (21 CFR 314.162)).
    Under Sec.  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 Sec. Sec.  
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-

[[Page 15633]]

release tablets, 10 mg, may be approved by the agency.

    Dated: March 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5975 Filed 3-25-05; 8:45 am]
BILLING CODE 4160-01-S