Alembic Pharmaceuticals receive USFDA approval for Divalproex Sodium capsules

Alembic Pharmaceuticals announced it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved product is therapeutically equivalent to the reference listed drug product, Depakote Sprinkle Capsules, 125 mg, manufactured by AbbVie.

Divalproex Sodium is an anti-epileptic drug used for monotherapy and adjunctive therapy in the treatment of complex partial seizures and simple and complex absence seizures. It is also prescribed as an adjunctive therapy for patients with multiple seizure types, including absence seizures. Detailed indications can be found in the product label.

The estimated market size for Divalproex Sodium Delayed-Release Capsules USP, 125 mg, is valued at US$ 61.1 million for the twelve months ending September 2024, according to data from IQVIA.

Alembic Pharmaceuticals has received a cumulative total of 220 ANDA approvals from the USFDA, comprising 193 final approvals and 27 tentative approvals.