Shilpa Medicare gets tentative US FDA nod for multiple sclerosis drug

Dimethyl Fumarate delayed release capsules is a generic of Tecfidera

Shilpa Medicare 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 (US FDA), Shilpa Medicare said in a BSE filing.

Dimethyl Fumarate delayed release capsules is a generic of Tecfidera, it added. Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Dimethyl Fumarate delayed release capsules is approximately $3.46 billion.