[Federal Register Volume 61, Number 226 (Thursday, November 21, 1996)]
[Notices]
[Pages 59233-59234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96P-0090]


Determination That Testosterone Propionate 2% Ointment 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 
testosterone propionate 2% ointment (Perandren Ointment) 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withdrawn from sale for reasons of safety or effectiveness.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 testosterone propionate 2% ointment.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7520 
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.
    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 Under FDA regulations, drugs are withdrawn from the 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 March 19, 1996, Richard Hamer Associates, Inc., submitted a 
citizen petition (Docket No. 96P-0090/CP1) under 21 CFR 10.25(a), 
10.30, and Sec. 314.161(b), requesting that the agency determine 
whether testosterone propionate 2% ointment 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 relist the drug in the Orange Book. Testosterone 
propionate 2% ointment (Perandren Ointment) was the subject of approved 
NDA 0-0499 held by Ciba Pharmaceutical Co. In the Federal Register of 
September 23, 1971 (36 FR

[[Page 59234]]

18885), FDA withdrew approval of NDA 0-0499 for Perandren Ointment 
based on the applicant's failure to submit required annual reports 
(section 505(e) of the act (21 U.S.C. 355(e)) and 21 CFR 314.80 and 
314.81).
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(c), has determined that testosterone propionate 2% ointment was 
not withdrawn from sale for reasons of safety or effectiveness and will 
relist testosterone propionate 2% ointment 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. ANDA's that refer to testosterone propionate 2% ointment 
may be approved by the agency.

    Dated: October 27, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-29766 Filed 11-20-96; 8:45 am]
BILLING CODE 4160-01-F