Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited 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, 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 USD 176 million.