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Shilpa Medicare has received tentative approval from the US health regulator for Dimethyl Fumarate delayed release capsules, used in the 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 today.
Dimethyl Fumarate delayed release capsules are a generic version of Tecfidera, it added.
Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Dimethyl Fumarate delayed release capsules stands at approximately $3.46 billion.
The company shares were trading higher by 4.65 per cent at Rs 391.40 on the BSE.
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