Glenmark gets USFDA approval for headache drug
New Delhi: Glenmark Pharmaceuticals Ltd on Wednesday said its subsidiary has received approval from the US health regulator to sell generic versions of AstraZeneca's Zomig and Zomig ZMT tablets, a migraine drug, in the American market.
Glenmark Generics Inc, a subsidiary of Glenmark, has received approval from US Food and Drug Administration (USFDA) for Zolmitriptan tablets and Zolmitriptan Orally Disintegrating tablets, Glenmark said in a statement.
"Glenmark will commence distribution of the product immediately," the Mumbai-based firm said.
Zolmitriptan Tablets and Zolmitriptan ODT are indicated for the acute treatment of migraine headaches in adults.
According to IMS Health, for the 12-month period ended December 2012, the products garnered annual sales of USD 176 million.
Glenmark's current portfolio consists of 85 products authorised for distribution in the US market.
Shares of Glenmark were trading at Rs 555 on the BSE in late afternoon trade, up 1.34 per cent from their previous close.