[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Notices]
[Pages 25497-25498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12690]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95P-0128]
Determination That Hydrocortisone Acetate Topical Ointment 2.5%
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
hydrocortisone (Cortef) acetate topical ointment 2.5% was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow sponsors to submit abbreviated new drug
applications (ANDA's) for hydrocortisone acetate topical ointment 2.5%.
FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1049.
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
[[Page 25498]]
subject of the ANDA is bioequivalent to the listed drug.
The 1984 amendments included what is now section 505(j)(6) of the
Federal Food, Drug, and Cosmetic Act (the 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 Under FDA regulations, drugs are withdrawn from the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the listed drug was withdrawn from sale for reasons of safety or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.
On May 12, 1995, Reed & Carnrick Pharmaceuticals submitted a
citizen petition (Docket No. 95P-0128/CP1) under 21 CFR 10.25(a) and
10.30 requesting that the agency determine whether hydrocortisone
acetate topical ointment 2.5% was withdrawn from sale for reasons of
safety or effectiveness and, if the agency determines that the drug was
not withdrawn from sale for reasons of safety or effectiveness, to keep
the drug in the ``Approved Drug Products with Therapeutic Equivalence
Evaluations.'' Hydrocortisone acetate topical ointment 2.5%, along with
the 1% strength, is the subject of approved NDA 8-917 held by the
Upjohn Co. (Upjohn). On July 28, 1953, Upjohn obtained approval to
market the 2.5% strength of hydrocortisone acetate topical ointment.
Upjohn withdrew the drug from sale in 1991.
FDA has reviewed its records and, under Secs. 314.161 and
314.162(c), has determined that hydrocortisone acetate topical ointment
2.5% was not withdrawn from sale for reasons of safety or effectiveness
and will continue to list hydrocortisone acetate topical ointment 2.5%
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 hydrocortisone
acetate topical ointment 2.5% may be submitted to the agency.
Dated: May 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-12690 Filed 5-20-96; 8:45 am]
BILLING CODE 4160-01-F
