Glenmark Generics has been granted final abbreviated new drug approvals (ANDA’s) from the United States Food and Drug Administration (US FDA) for zolmitriptan tablets, 2.5 and 5mg and zolmitriptan orally disintegrating tablets (ODT), 2.5 and 5mg. 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 $ 176 million.
Glenmark’s current portfolio consists of 85 products authorised for distribution in the US marketplace and 50 ANDA’s pending approval with the US FDA. 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.
EP News Bureau – Mumbai