Glenmark Pharma's arm receives final ANDA approvals for Zolmitriptan Tablets from USFDA

15 May 2013 Evaluate

Glenmark Generics Inc, USA, a subsidiary of Glenmark Pharmaceuticals has been granted final abbreviated new drug approvals (ANDA’s) from the United States Food and Drug Administration (USFDA) for Zolmitriptan Tablets, 2.5 and 5mg and Zolmitriptan Orally Disintegrating Tablets, 2.5 and 5mg. The pharma major will commence distribution of the product immediately.

Zolmitriptan Tablets and Zolmitriptan ODT are Glenmark’s generic versions of Zomig and Zomig ZMT by AstraZeneca, indicated for the acute treatment of migraine headaches in adults. According to IMS Health for the 12 month period ending December 2012, the products garnered annual sales of $176 million.

Glenmark’s current •portfolio consists of 85 products authorized for distribution in the US marketplace and 50 ANDA’s pending approval with the USFDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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