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Glenmark gets ANDA approval for generic migraine drug

15 May 2013 | News | By BioSpectrum Bureau

Glenmark gets ANDA approval for generic migraine drug

Glenmark Generics, a US based 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, and Zolmitriptan Orally Disintegrating Tablets (ODT). Glenmark 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 US$ 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 US FDA. In addition to these internal filings, Glenmark Generics continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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