Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules USP, 125 mg

Alembic Pharmaceuticals Limited (Alembic) 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 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. Refer label for a detailed indication.

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

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

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1050.15 as compared to the previous close of Rs. 1056.00. The total number of shares traded during the day was 3234 in over 420 trades.

The stock hit an intraday high of Rs. 1069.95 and intraday low of 1044.00. The net turnover during the day was Rs. 3416504.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANdA DivalproexSodium DelayedReleaseCapsules