BackGlenmark to launch anti-hypertension drug in US, gets FDA nod
Glenmark to commence distribution of anti-hypertension drug Telmisartan tablets in US immediately
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New Delhi: Glenmark Pharmaceuticals will launch a generic version of anti-hypertension drug Telmisartan tablets in the US market following receipt of approval from the country’s health regulator.
Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics Ltd, has been granted final abbreviated new drug approval (ANDA) from the US Food and Drug Administration (USFDA) for Telmisartan tablets, the company said in a filing to BSE.
“Glenmark will commence distribution of the product immediately," it added. The approval is for the 20mg, 40mg and 80mg tablets.
Telmisartan tablets are Glenmark’s generic version of Boehringer Ingelheim’s Micardis. Telmisartan is indicated for the treatment of hypertension. For the 12-month period ended March 2014, Telmisartan garnered annual sales of $250 million, according to IMS Health, the company said.
Glenmark’s current portfolio consists of 92 products authorized for distribution in the US market and 73 ANDAs are pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals ended at ₹ 562.35 per scrip, down 4.55% on the BSE.
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