Glenmark Pharmaceuticals' US arm has received final approval from USFDA for its Nitroglycerin sublingual tablets used for preventing chest pain due to coronary artery disease.
Glenmark Pharmaceuticals Inc has received final approval by the US health regulator for Nitroglycerin sublingual tablets USP in the strengths of 0.3 mg, 0.4 mg, and 0.6 mg, the company said in a statement today.
The tablets are generic versions of Pfizer Inc’s Nitrostat sublingual tablets in the same strengths, it added.
According to IMS health sales data for the 12 months ended July, the Nitrostat sublingual tablets 0.3 mg, 0.4 mg, and 0.6 mg (brand and all available therapeutic equivalents) achieved annual sales of around $112.7 million, Glenmark said.
The company’s current portfolio consists of 125 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDAs) which are pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were trading down by 0.5 per cent at Rs 612.35 on the BSE.