[Federal Register Volume 63, Number 85 (Monday, May 4, 1998)]
[Notices]
[Pages 24556-24557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11684]


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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Withdrawn From Sale for Reasons of Safety or Effectiveness; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending a previous 
determination regarding the fact that testosterone propionate 2% 
ointment (Perandren Ointment) was not withdrawn from sale for reasons 
of safety or effectiveness. FDA has determined that it is not 
appropriate at this time to accept abbreviated new drug applications 
(ANDA's) for testosterone propionate 2% ointment.

FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: 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 a 
``listed drug.'' A listed drug is one that has an effective approval, 
either under section 505(c) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 355(c)) for safety and effectiveness or under 
section 505(j) of the act, which has not been withdrawn for reasons of 
safety or effectiveness (21 CFR 314.3, see also 21 U.S.C. 355(j)(6)). 
Neither at the time of ANDA submission nor at the time of ANDA approval 
is it essential that a listed drug be currently marketed.
    FDA's ``Approved Drug Products with Therapeutic Equivalence 
Evaluations'' (popularly referred to as the ``Orange Book'') contains 
the official register of listed drugs, and a drug is removed from this 
register in either of two ways. First, a listed drug is removed if the 
agency withdraws or suspends approval of the drug's new drug 
application (NDA) or ANDA for reasons of safety or effectiveness. 
Second, in the case of a listed drug that was discontinued from sale 
but did not have its approval withdrawn or had its approval withdrawn 
for reasons other than safety or effectiveness, the drug is removed if 
FDA determines that it was discontinued from sale for reasons of

[[Page 24557]]

safety or effectiveness (21 CFR 314.162). FDA may be called upon to 
make such a finding when petitioned by a potential ANDA applicant 
(Sec. 314.161 (21 CFR 314.161)).
    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 314.161(b), requesting that the agency determine whether 
testosterone propionate 2% ointment was discontinued from sale for 
reasons of safety or effectiveness and, if the agency determines that 
the drug was not discontinued 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 NDA 0-
0499 held by Ciba Pharmaceutical Co. This NDA was submitted to FDA on 
January 24, 1939, and under the procedures of the act at that time, the 
NDA ``became effective'' (the statutory equivalent of ``approval'' 
under the act as it appears now) on March 7, 1939, 23 years before 
passage of the 1962 amendments to the act. The significance of these 
dates is that from 1938 through 1962, FDA reviewed drugs only to pass 
upon their safety. The 1962 amendments to the act (Pub. L. 87-781 
(October 10, 1962)) required FDA to review drugs not only for safety, 
but also for effectiveness. The effectiveness standard applied both 
prospectively to new drugs entering the market and retrospectively to 
drugs whose applications became effective between 1938 and 1962.
    In the Federal Register of September 23, 1971 (36 FR 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 and 21 CFR 314.80 and 314.81).
    In the Federal Register of December 6, 1996 (61 FR 64754), FDA in 
responding to the Hamer petition, announced its determination that 
testosterone propionate 2% ointment (Perandren Ointment) was not 
discontinued from sale for reasons of safety or effectiveness. In that 
same notice, FDA announced that this determination will allow FDA to 
approve ANDA's for testosterone propionate 2% ointment. Upon further 
investigation, however, FDA has determined that NDA 0-0499 for 
Perandren Ointment was never approved as effective for any of its 
labeled indications and, therefore, was never a ``listed drug'' such 
that it could be ``relisted.'' As discussed previously, for a drug 
approved under section 505(c) of the act to be a ``listed drug,'' it 
must have been approved for effectiveness as well as safety. No 
information was ever submitted on the effectiveness of this product 
prior to its withdrawal of approval in 1971. So, while it remains true 
that NDA 0-0499 was not discontinued from sale for reasons of safety or 
effectiveness, it is not appropriate at this time to accept ANDA's for 
testosterone propionate 2% ointment.
    The Federal Register notice of December 6, 1996, is amended insofar 
as it is inconsistent with the findings of this notice.

    Dated: April 27, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-11684 Filed 5-1-98; 8:45 am]
BILLING CODE 4160-01-F