Zydus Gets USFDA Nod For Generic Absorica Acne Treatment

Zydus Lifesciences Ltd. on Friday said it has secured final approval from the US Food and Drug Administration to market Isotretinoin capsules in six strengths — 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg.

The capsules, a generic version of Absorica, will be manufactured at the company’s Moraiya facility near Ahmedabad, Zydus said in a filing to the exchanges.

Isotretinoin is prescribed for treating severe, disfiguring nodular acne that hasn’t responded to other therapies. The drug generated annual sales of $115.4 million in the US for the 12 months to March, the company said, citing IQVIA data.