Zydus Cadila gets FDA approval for Apremilast Tablets

Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) to market Apremilast Tablets, a drug for psoriasis.

The approval is for the strengths of 10 mg, 20 mg, and 30 mg.

Apremilast Tablets is a generic of Otezla Tablets, which is indicated for the treatment of adults having moderate to severe plaque psoriasis and are candidates for phototherapy or systemic therapy.

Zydus Cadila gets FDA approval for Apremilast Tablets. Photo courtesy of Zydus Cadila.

Zydus Cadila said that the psoriasis drug will be manufactured at its formulation manufacturing facility at the SEZ, Ahmedabad.

The Indian pharma group has taken its approvals to 323 and has to date filed more than 400 ANDAs since the start of the filing process in FY 2003-04.

Earlier this month, Zydus Cadila was granted final approval from the FDA to market Vortioxetine Tablets.