[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Pages 64754-64755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96P-0090]


Determination That Testosterone Propionate 2% Ointment Was Not 
Withdrawn From Sale for Reasons of Safety or Effectiveness

    Note: This document was originally published at 61 FR 59233, on 
Thursday, November 21, 1996. The document was inadvertently 
published with an incorrect signature. For the convenience of the 
reader, the document is being republished in its entirety.

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withdrawn from sale for reasons of safety or effectiveness.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)

[[Page 64755]]

(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-0499 held by Ciba Pharmaceutical Co. In the Federal Register of 
September 23, 1971 (36 FR 18885), FDA withdrew approval of NDA- 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: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31119 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F