[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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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
