[Federal Register: September 10, 2003 (Volume 68, Number 175)]
[Notices]               
[Page 53384-53385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se03-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0384]

 
Hoffmann-La Roche, Inc.; Withdrawal of Approval of a New Drug 
Application

AGENCY: Food and Drug Administration, HHS.

[[Page 53385]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for TEGISON (etretinate) Capsules held 
by Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110. 
Hoffmann-La Roche has requested that approval of this application be 
withdrawn because the product is no longer marketed, thereby waiving 
its opportunity for a hearing.

DATES: Effective September 10, 2003.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In a letter dated September 23, 1999, 
Hoffmann-La Roche requested that FDA withdraw approval of NDA 19-369 
for TEGISON (etretinate) Capsules, stating that it had discontinued 
marketing the product. The letter also stated that TEGISON had been 
replaced by NDA 19-821 for SORIATANE (acitetrin) and that TEGISON was 
not withdrawn for safety reasons. In FDA's acknowledgment letter of 
December 30, 2002, the agency informed Hoffmann-La Roche that TEGISON 
(etretinate) Capsules, a treatment for psoriasis, was removed from the 
market, under Sec.  314.150(d) (21 CFR 314.150(d)), because it poses a 
greater risk of birth defects than SORIATANE (acitretin), the product 
that replaced TEGISON. Acitretin, the active metabolite of etretinate, 
has a much shorter half-life than etretinate. Thus, acitretin poses a 
risk of serious birth defects for a shorter period of time than 
etretinate after a woman stops taking the drug product. Hoffmann-La 
Roche waived its opportunity for a hearing, provided under Sec.  
314.150(a) and (b).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355(e)) and under authority delegated 
to the Director, Center for Drug Evaluation and Research (21 CFR 
5.105(a)), approval of NDA 19-369, and all amendments and supplements 
thereto, is hereby withdrawn, effective September 10, 2003.
    Distribution of this product in interstate commerce without an 
approved application is illegal and subject to regulatory action (see 
sections 505(a) and 301(d) of the act (21 U.S.C. 355(a) and 331(d)).

    Dated: August 5, 2003.
Steven K. Galson,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 03-22956 Filed 9-9-03; 8:45 am]

BILLING CODE 4160-01-S