The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.
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Shilpa Medicare said it has received tentative approval from the US health regulator for Dimethyl Fumarate delayed release capsules, used for treatment of relapsing forms of multiple sclerosis.
The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.
Dimethyl Fumarate delayed release capsules is a generic of Tecfidera, it added.
First Published on Nov 16, 2018 10:55 am
