Generic drugmaker Mylan Inc. (MYL) said Wednesday that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Zolmitriptan tablets, 2.5 mg and 5 mg.
The product is the generic version of IPR Pharmaceuticals Inc.'s Zomig Tablets and is indicated for the acute treatment of migraine with or without aura in adults.
Zolmitriptan tablets are for use only where a clear diagnosis of migraine has been established. If a patient does not respond after the first dose, a healthcare provider should reconsider the diagnosis before re-administering. The product is not indicated for the prevention of migraine attacks or cluster headaches.
Zolmitriptan Tablets, 2.5 mg and 5 mg, had U.S. sales of about $152.8 million for the 12 months ending March 31, 2013, according to IMS Health. Mylan said it has begun shipping the product.
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