Glenmark Generics receives tentative US FDA approval for rizatriptan benzoate

Glenmark Generics has announced that United States Food and Drug Administration (US FDA) has granted tentative approval for rizatriptan benzoate tablets, an anti-migraine drug, its generic version of Merck’s Maxalt tablets. According to IMS Health for the 12 month period ending June 2012, t Rizatriptan Benzoate immediate release tablets achieved sales of $ 315 million.

Glenmark’s current portfolio consists of 81 products authorised for distribution in the US marketplace and 41 ANDA’s pending approval with the US FDA.

EP News Bureau

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