Zydus Cadila arm gets USFDA nod for plaque psoriasis drug Apremilast

Ahmedabad: Drugmaker Zydus Cadila has recently announced that the company's U. S. subsidiary Zydus Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration (USFDA) to market Apremilast Tablets in the strengths of 10 mg, 20 mg, 30 mg (US RLD: Otezla Tablets).

Zydus' Apremilast Tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Plaque psoriasis is the most common form and affects 85–90% of people with psoriasis. It typically appears as raised areas of inflamed skin covered with silvery-white, scaly skin. These areas are called plaques and are most commonly found on the elbows, knees, scalp, and back.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 323 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

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