Glenmark Pharma received approval from USFDA to market drug for relapsing multiple sclerosis

Glenmark Pharmaceutical a global medical drug manufacturer and distributor on Wednesday during the interview said that it has received the final approval from the US health regulatory authority for Dimethyl Fumarate delayed-release capsules. The capsule is majorly used for the treatment of replacing forms of multiple sclerosis in adults. The product that received the approach form the regulatory body is a generic version of Biogen Inc’s Tecfidera delayed-release capsules.

The United States Food and Drug Administration (USFDA) has granted Glenmark Pharmaceuticals Inc. the approval for Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg. The company during the regulatory said that IQVIA sales data for the 12 month period ending August 2020, Tecfidera delayed-release capsules, 120 mg and 240 mg, market achieved annual sales of approximately USD 3.8 billion.

The company is investing high for the research and development activities and in the current portfolio the company holds 164 products that are authorized for the distribution in the US market. In addition, more 46 abbreviated new drug applications are pending approval with the USFDA. Shares of Glenmark Pharma were trading at Rs 494.85 per scrip on the BSE, up 0.94 per cent over previous close.

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Dr.James Robinson

Dr.James Robinson, MD, MS is an Associate Professor of Epidemiology and Medicine DescriptionThe Icahn School of Medicine at Mount Sinai is a private graduate medical school in Manhattan, New York City, where he serves as a founding co-Director of the Center for Drug Safety and Effectiveness. He is a practising general internist and pharmacoepidemiologist and is internationally recognised for his research examining prescription drug utilisation. Dr.James Robinson is the author of over a hundred scientific articles and book chapters, is a frequent speaker on health care issues and has served on numerous editorial and advisory boards.

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