Drug firm Zydus Cadila said it has received approval from the US health regulator to market Apremilast tablets, used to treat plaque psoriasis, in the American market.
The company's US-based subsidiary Zydus Pharmaceuticals (USA) 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 in the US market, Zydus Cadila said in a statement.
The company's product is the generic version of Otezla tablets, which are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The drug will be manufactured at the Zydus group's formulation manufacturing facility at the special economic zone (SEZ), Ahmedabad, the drug firm noted.
The group now has 323 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04.