newsmantra.in l Latest news on Politics, World, Bollywood, Sports, Delhi, Jammu & Kashmir, Trending news | News Mantra
Health

Alembic Pharmaceuticals announces USFDA Final Approval for Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration

7th August 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel). Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Refer label for a detailed indication.

Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of US$ 21 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 212 ANDA approvals (184 final approvals and 28 tentative approvals) from USFDA.

Explore More:

Muthoottu Mini facilitates education access to 22,000 underprivileged children in South India through school supplies

Related posts

Zydus Lifesciences initiates Phase II clinical trial of ZYIL1, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS)

Newsmantra

Policybazaar Redefines Strength: Celebrating Courage in Mental Health Battles

Newsmantra

Severe Depression, Anxiety, and Relationship Struggles on the Rise Among Bengaluru Youth, Finds Mpower Data

Newsmantra

This website uses cookies to improve your experience. We'll assume you're ok with this, but you can opt-out if you wish. Accept Read More