Zydus Lifesciences bags USFDA final approval for Isotretinoin Capsules

1 Sep 2023 , 12:01 PM

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) announced in an exchange filing with the bourses that it has received final FDA approval for Isotretinoin Capsules USP, 10 mg, 20 mg, 30 mg, and 40 mg.

Isotretinoin Capsules are used for the treatment of severe cystic acne (also known as nodular acne) that has not responded to prior treatments (such as topical benzoyl peroxide or clindamycin or oral tetracycline or minocycline).

The medicine will be made in Moraiya, Ahmedabad (India), at the group’s formulation production facility.

In the United States, Isotretinoin Capsules USP, 10 mg, 20 mg, 30 mg, and 40 mg had yearly sales of USD 165 million. Since the beginning of the filing procedure in FY 2003-04, the group has received 378 approvals and has filed over 444 ANDAs.

At around 11.55 AM, Zydus Lifesciences was trading 1.41% lower at Rs 617, against the previous close of Rs 625.85 on NSE. The counter touched an intraday high and low of Rs 629.10 and Rs 616.20, respectively.

For feedback and suggestions, write to us at [e-mail]