New Delhi, Dec 20 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic Divalproex Sodium delayed-release capsules, used in the treatment of epilepsy.
The approval granted by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of Divalproex Sodium delayed-release capsules of strength 125 mg, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD), Depakote Sprinkle capsules, 125 mg of AbbVie Inc, it added.
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, it added.
Citing IQVIA data, the company said Divalproex Sodium delayed-release capsules 125 mg have an estimated market size of USD 61.1 million for 12 months ended September 2024.