[Federal Register Volume 66, Number 101 (Thursday, May 24, 2001)]
[Notices]
[Pages 28753-28754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P-1340]


Determination That ROWASA (mesalamine) Rectal Suppositories, 500 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 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) is announcing its 
determination that ROWASA (mesalamine) Rectal Suppositories, 500 
milligrams (mg) was not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for

[[Page 28754]]

mesalamine rectal suppositories, 500 mg.

FOR FURTHER INFORMATION CONTACT: S. Mitchell Weitzman, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5670.

SUPPLEMENTARY INFORMATION: 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. 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 ANDAs 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 Under FDA regulations, drugs are withdrawn from the list if the 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).
    Under Sec. 314.161(a)(1) (21 CFR 314.161(a)(1)), 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. FDA may not approve an ANDA that 
does not refer to a listed drug.
    On June 12, 2000, Able Laboratories, Inc., under 21 CFR 10.30, 
submitted a citizen petition (Docket No. 00P-1340/CP1) to FDA. The 
petition requested that the agency determine whether mesalamine Rectal 
Suppositories, 500 mg, was withdrawn from sale for reasons of safety or 
effectiveness. Mesalamine rectal suppositories, 500 mg, is the subject 
of NDA 19-919. FDA approved NDA 19-919, held by Solvay Pharmaceuticals, 
Inc. (Solvay), on December 18, 1990. On July 1, 1999, Solvay informed 
FDA that ROWASA Rectal Suppositories had been voluntarily recalled 
after repeated, sporadic dissolution specification failures were 
observed.
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that Solvay's decision to recall and terminate marketing 
mesalamine rectal suppositories, 500 mg, was not for reasons of safety 
or effectiveness. Accordingly, the agency will continue to list 
mesalamine rectal suppositories, 500 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 mesalamine rectal suppositories, 500 
mg, may be approved by the agency.

    Dated: May 17, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13169 Filed 5-23-01; 8:45 am]
BILLING CODE 4160-01-S