Zydus Receives Approval From USFDA For Isotretinoin Capsules

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg, a generic equivalent of reference listed drug Accutane Capsules, the company said in an exchange filing on Thursday. 

Isotretinoin Capsules is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (such as benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). 

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India). 

Section 505-1 of the FD&C Act authorises FDA to require the submission of a Risk Evaluation and Mitigation Strategy (REMS) for this product. Zydus’ proposed REMS has also been approved by the FDA.

Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg had annual sales of USD 165 million in the United States (IQVIA MAT July 2023).