FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions

FDA supports new ANDA prioritization pilot to support US generic drugs

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma

Alembic gets FDA final approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product