Glenmark cleared to market Frova generic

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MUMBAI, India — Glenmark Pharmaceuticals USA has received approval from the Food and Drug Administration for frovatriptan succinate tablets 2.5 mg, a medication for migraine headaches.

Glenmark said Monday that its product is a generic version of Frova tablets (2.5 mg) from Endo Pharmaceuticals Inc. Frova is indicated to help provide migraine pain relief and ease the symptoms of migraines, but not to prevent headaches or reduce the number of attacks.

For the 12-month period ending in January 2016, Frova totaled U.S. sales of approximately $87.8 million, according to IMS Health data reported by Glenmark.

Glenmark added that its current portfolio consists of 108 products authorized for distribution in the U.S. market and 61 ANDAs pending approval with the FDA.


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