Alembic Pharma gets USFDA nod for seizure treatment drug

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Divalproex Sodium Delayed-Release Capsules.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules.

Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures.

According to IQVIA, Divalproex Sodium Delayed-Release Capsules USP, 125 mg, have an estimated market size of $61.1 million for twelve months ending September 2024.

Alembic has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA.

Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients.

The pharmaceutical companys consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.

The scrip rose 0.78% to currently trade at Rs 1,058.35 on the BSE.

Powered by Capital Market - Live News