Alembic Pharmaceuticals gets USFDA’s final approval for Divalproex Sodium Delayed-Release Capsules

20 Dec 2024 Evaluate

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

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of $61.1 million for twelve months ending September 2024 according to IQVIA. The company has a cumulative total of 220 ANDA approvals (193 final approvals and 27 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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