Human drugs: New drug applications— Testosterone propionate 2% ointment,

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Federal Register: May 4, 1998 (Volume 63, Number 85)NoticesPage 24556-24557From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr04my98-98

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 96P-0090Determination That Testosterone Propionate 2% Ointment Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Amendment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.

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a previous determination regarding the fact that testosterone propionate 2% ointment (Perandren Ointment) was not withdrawn from sale for reasons of safety or effectiveness.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Act (the act) (21 U.S.C. 355(c)) for safety and effectiveness or under section 505(j) of the act, which has not been withdrawn for reasons of safety or effectiveness (21 CFR 314.3, see also 21 U.S.C. 355(j)(6)).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 Second, in the case of a listed drug that was discontinued from sale but did not have its approval withdrawn or had its approval withdrawn for reasons other than safety or effectiveness, the drug is removed if FDA determines that it was discontinued from sale for reasons of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. 98-11684Filed5-1-98; 8:45 amBILLING CODE 4160-01-F

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