New Delhi: Glenmark Pharmaceuticals on Wednesday said its 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 from 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.
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 USD 112.7 million, Glenmark said.
The company’s current portfolio consists of 125 products authorized for distribution in the US marketplace and 61 abbreviated new drug applications (ANDAs) which are pending approval with the USFDA, it added.