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Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US health regulator for Deferasirox tablets for oral suspension. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of exjade1 tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation," the company said in a filing to the BSE. The tablet is used to treat high levels of iron in the body caused by multiple blood transfusions. According to IQVIA sales data for the 12-month period ending November 2019, exjade tablets for oral suspension -- 125 mg, 250 mg and 500 mg -- had annual sales of approximately USD 106.4 million (about Rs 750 crore). Glenmark's current portfolio consists of 165 products authorised for distribution in the US market and 43 ANDAs pending approval with the US FDA. In addition
Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis. The tentative nod granted by US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg. These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement. Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately USD 3.7 billion. Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.