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

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.


Effective Date: November 22, 2010.

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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.

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Hoffmann-La Roche Inc. has requested that FDA withdraw approval of NDA 18-662, ACCUTANE (isotretinoin) Capsules, under the process in § 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 § 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Drugs, approval of NDA 18-662, ACCUTANE (isotretinoin) Capsules, and all amendments and supplements thereto, is hereby withdrawn, effective November 22, 2010.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7, 2010 (75 FR 39024), FDA issued a notice announcing its determination that ACCUTANE (isotretinoin) Capsules were not withdrawn from sale for reasons of safety or effectiveness, and isotretinoin continues to be marketed under approved abbreviated new drug applications (ANDAs).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.

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Dated: November 2, 2010.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 2010-29348 Filed 11-19-10; 8:45 am]