Generics
US FDA grants final approval to Cipla's abbreviated new drug application for Dimethyl Fumarate DR Capsules
29 September 2020 -

The United States Food and Drug Administration (FDA) has granted final approval to India-based Cipla Limited (BSE: 500087)(NSE: CIPLA EQ) for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pak, it was reported on Monday.

The product is an AB-rated generic therapeutic equivalent version of Biogen IDEC's Tecfidera.

The product is intended to be used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is available for shipping immediately.

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