Alembic Pharma bags USFDA nod for anti-epileptic drug

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-20T16:00:10+05:30 | Updated On 20 Dec 2024 4:00 PM IST

Vadodara: Alembic Pharmaceuticals Limited has 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.

Medical Dialogues team had earlier reported that the USFDA had issued final approval to the Company for its ANDA Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg.

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.

Alembic Pharmaceuticals is engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products. Founded in 1907 and headquartered in Vadodara, Gujarat, Alembic specializes in generic drugs, active pharmaceutical ingredients (APIs), and over-the-counter (OTC) products. The company has a global presence, with operations in over 75 countries, including the U.S., Europe, and emerging markets. Alembic is known for its medicines across therapeutic segments such as cardiovascular, anti-infective, pain management, and oncology.

alembic pharmaalembic pharma newsUSFDADivalproex Sodium Delayed Release CapsulesDepakote Sprinkle Capsulesabbvie

Ruchika Sharma

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751