[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Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the 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