[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0586]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules 
held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110-
1199. Hoffmann-La Roche Inc. notified the Agency in writing that the 
drug product was no longer marketed and requested that the approval of 
the application be withdrawn.

DATES: Effective Date: November 22, 2010.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche Inc. has requested that 
FDA withdraw approval of NDA 18-662, ACCUTANE (isotretinoin) Capsules, 
under the process in Sec.  314.150(c) (21 CFR 314.150(c)), stating that 
the drug product is no longer marketed. Hoffmann-La Roche Inc. has 
also, by its request, waived its opportunity for a hearing. Withdrawal 
of approval of an application under Sec.  314.150(c) is without 
prejudice to refiling.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner of Food and Drugs, approval of NDA 18-662, ACCUTANE 
(isotretinoin) Capsules, and all amendments and supplements thereto, is 
hereby withdrawn, effective November 22, 2010. Introduction or delivery 
for introduction into interstate commerce of a product without an 
approved application violates sections 301(a) and (d) of the FD&C Act 
(21 U.S.C. 331(a) and (d)). ACCUTANE (isotretinoin) Capsules that are 
in inventory on the date that this notice becomes effective (see the 
DATES section) may continue to be dispensed until the inventories have 
been depleted or the drug product has reached its expiration date or 
otherwise become violative, whichever occurs first.
    In the Federal Register of July 7, 2010 (75 FR 39024), FDA issued a 
notice announcing its determination that ACCUTANE (isotretinoin) 
Capsules were not withdrawn from sale for reasons of safety or 
effectiveness, and isotretinoin continues to be marketed under approved 
abbreviated new drug applications (ANDAs). The holders of ANDAs for 
isotretinoin are subject to an approved risk evaluation and mitigation 
strategy (REMS) under section 505-1 of the FD&C Act (21 U.S.C. 355-1), 
and the REMS, known as the iPLEDGE program, remains in effect.

    Dated: November 2, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-29348 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P