USFDA Says Yes to Zydus: Isotretinoin Capsules Ready to Shine

Image Source: Medical Dialogues

Zydus Lifesciences has obtained final USFDA approval to launch its generic Isotretinoin Capsules in the United States, a major development that augments the company's position in the American dermatology market. The approval is for several dosage strengths and arrives on the back of strong annual sales for the category, which positions Zydus to corner some of the profitable market for acne treatments.

Approval Details

Zydus Lifesciences achieved final USFDA approval for Isotretinoin Capsules USP in 10 mg, 20 mg, 30 mg, and 40 mg strengths.
The approved drug is the generic version of the reference listed drug Accutane Capsules.

Therapeutic Use

Isotretinoin is indicated in the treatment of severe cystic (nodular) acne that has failed other therapies, including topical benzoyl peroxide, clindamycin, or oral antibiotics such as tetracycline or minocycline.

Manufacturing and Compliance

The capsules will be manufactured at Zydus' formulation manufacturing plant in Moraiya, Ahmedabad, India.
The USFDA also approved Zydus' Risk Evaluation and Mitigation Strategy (REMS), comprising its iPLEDGE REMS program that ensures safe treatment with isotretinoin owing to its established side effects and teratogenic risk.

Market Impact

Based on IQVIA MAT data (July 2023), Isotretinoin Capsules in these strengths had annual US sales of around $165 million.
With this clearance, Zydus has now attained 378 USFDA approvals and made more than 444 Abbreviated New Drug Applications (ANDAs) since FY 2003-04.

Stock Market Reaction

Shares of Zydus Lifesciences registered slight fluctuations following the announcement, trading slightly lower on the BSE.

Significance of the Approval

The approval enhances Zydus Lifesciences' share in the US generic pharmaceuticals segment, especially in the field of dermatology.
It offers US patients a less expensive option for a vital acne treatment, increasing access to a vital drug in severe cases.

Sources: BW Healthcare World, CNBC TV18, Express Pharma, Business Standard, Medical Dialogues