Glenmark Pharma, one of the leading US drug maker on Monday said it has received tentative approval from the US health regulator FDA for anticoagulant Dabigatran Etexilate capsules. The FDA approved product is a generic version of Boehringer Ingelheim Pharmaceuticals’ Pradaxa capsules. These tablets are used to prevent the formation of blood clots due to a certain irregular heart rhythm.
FDA tentative approval was given to Dabigatran Etexilate capsules in the strengths of 75 mg, 110 mg, and 150 mg, the company said in a regulatory filing. Glenmark quoting a sale report said Pradaxa capsules, 75, 110 mg and 150 mg, market achieved annual sales of approximately USD 550.9 million. It also said its current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 abbreviated new drug applications are pending approval with the USFDA.
At present the Company's shares were trading 2.32 per cent higher at Rs 528 per scrip on the BSE. In the month of November, the drug maker got final approval from FDA for Tacrolimus capsules of strengths 0.5 mg, 1 mg and 5 mg which is used as immuno-suppressant. The tablet is used for preventing organ rejection in certain patients following liver, kidney, or heart transplant.
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