[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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the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listed drug was withdrawn from sale for reasons of safety or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
