Alembic Pharma Secures Eight US FDA approvals in Q3FY24

Alembic Pharmaceuticals Limited has gained FDA approval for eight of its Abbreviated New Drug Applications (ANDA) in Q3FY24.

The company has received five final approvals that includes selexipag tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg, dapsone gel, 7.5%, fluorouracil Injection USP 5g/100mL (50 mg/mL), pharmacy bulk package (Vial), carmustine for injection USP 100 mg/vial (Single-dose Vial) and acyclovir cream, 5%.

The company has also received three tentative approvals that includes rivaroxaban tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, dapsone gel, 7.5%, bromfenac ophthalmic solution, 0.07%., and osimertinib tablets, 40 mg and 80 mg, as per pharmabiz   Actelion Pharmaceuticals US, Inc.'s Selexipag tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg with brand name Uptravi tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Rivaroxaban tablets, USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, marketed by Janssen Pharmaceuticals, Inc. under the brand name Xarelto tablets. Rivaroxaban pills are prescribed to people with nonvalvular atrial fibrillation to minimize the risk of stroke and systemic embolism. It is also used to treat deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and/or PE in patients who are still at risk for recurrent DVT and/or PE after completing at least 6 months of initial treatment.