FDA approves Alembic’s psoriasis drug

Anupama Ghosh Updated - August 07, 2024 at 08:53 PM.

Alembic Pharmaceuticals Limited announced it has received final approval from the US Food and Drug Administration for psoriasis drug Acitretin in 10 mg, 17.5 mg, and 25 mg strengths.

Alembic Pharmaceuticals Limited shares were trading at ₹1,218.65, up by 32 points (2.7 per cent) on NSE and ₹1,218.95, up by 34.50 points (2.91 per cent) on BSE at around 3 pm.

Acitretin is a retinoid medication related to vitamin A that is used to treat severe psoriasis in adults. According to the National Institutes of Health, retinoids play a crucial role in regulating the immune system, cellular growth, and differentiation. They also have anti-inflammatory effects and can inhibit tumour growth.

This approval marks Alembic’s 212th ANDA approval from the USFDA, including 184 final approvals and 28 tentative approvals. The generic is therapeutically equivalent to Stiefel Laboratories’ Soriatane capsules.

The estimated market size for Acitretin capsules was $21 million for the 12 months ending June 2024, according to IQVIA data.

Published on August 7, 2024 11:52

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