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Zydus gets final USFDA approval to market Apremilast tablets

DTMT Network

Zydus Cadila’s US subsidiary Zydus Pharmaceuticals  has received final approval from the USFDA to market Apremilast Tablets in the strengths of 10 mg, 20 mg, 30 mg (US RLD: Otezla® Tablets).

“Apremilast tablets 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 group’s formulation manufacturing facility at the SEZ, Ahmedabad,” Zydus said in a press release on September 24, 2021.

“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,” the company added.
    

 


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