Shilpa Medicare gets tentative American health regulator nod for Apremilast tablets

Drug firm on Friday said it has received tentative approval from the US health regulator for Apremilast tablets, used in the treatment of psoriatic arthritis. The newly approved product is a generic equivalent of reference listed drug (RLD) Otezla of Celgene.

The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.

Shilpa Medicare said the ANDA was filed as a 'First to File' submission on NCE -1 date to seek eligibility for 180 days exclusivity.

Quoting IQVIA MAT Q2 2020 data, the company said the US market for Apremilast tablets, 10 mg, 20 mg, and 30 mg is approximately USD 2.4 billion.

Shares of Shilpa Medicare were trading at Rs 379.80, down 1.11 per cent on BSE.