FDA approves Roxane's Naratriptan Tablets ANDA

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Jul 9 2010

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Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Administration. The product is available in bottles of 9 for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Naratriptan Tablets USP are AB rated to AMERGE® (naratriptan hydrochloride) tablets. Annual sales of AMERGE® are approximately $60.2 Million(1). AMERGE® Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

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Roxane Laboratories, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Food, Migraine, New Drug Application

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