[Federal Register Volume 61, Number 222 (Friday, November 15, 1996)]
[Notices]
[Pages 58565-58566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96P-0212]


Determination That Ibuprofen 200-Milligram Capsule 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Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
ibuprofen (Midol) 200-milligram (mg) capsule 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withdrawn from sale for reasons of safety or effectiveness.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 ibuprofen 200-mg capsule.

FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress passed into law 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.

[[Page 58566]]

    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,'' 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 Under FDA regulations, drugs are withdrawn from the list if the 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)). 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.
    Ibuprofen (Midol) 200-mg capsule is the subject of 
approved ANDA's 70-626 and 71-002. On September 7, 1987, Sterling 
Winthrop, Inc., (Winthrop) obtained approval to market the ibuprofen 
200-mg capsule. Winthrop never in fact marketed this drug product. The 
right to market the Midol 200-mg capsule was subsequently 
transferred to Bayer Corp., which never marketed the drug product and 
has indicated that it has no plans to market it in the future.
    On June 27, 1996, Private Formulations, Inc., submitted a citizen 
petition (Docket No. 96P-0212/CP1) under 21 CFR 10.30 to FDA requesting 
that the agency determine whether ibuprofen 200-mg capsule was 
withdrawn from sale for reasons of safety or effectiveness. FDA has 
determined that, for purposes of Secs. 314.161 and 314.162(c), never 
marketing an approved drug product is equivalent to withdrawing the 
drug from sale.
    FDA has reviewed its records and under Secs. 314.161 and 314.162(c) 
has determined that the ibuprofen 200-mg capsule was not withdrawn from 
sale for reasons of safety or effectiveness. Accordingly, the agency 
will maintain ibuprofen 200-mg capsule in the ``Discontinued Drug 
Product List'' contained in the ``Approved Drug Products with 
Therapeutic Equivalence Evaluations.'' The ``Discontinued Drug Product 
List'' lists, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDA's that refer to ibuprofen 200-mg capsule may be 
approved by the agency.

    Dated: November 7, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29238 Filed 11-14-96; 8:45 am]
BILLING CODE 4160-01-F