[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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the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the listed drug was withdrawn from sale for reasons of safety or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
