Alembic Pharma bags USFDA nod for anti-epileptic drug

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-12-20 10:30 GMT   |   Update On 2024-12-20 10:30 GMT

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.

Read also: Alembic Pharma bags USFDA tentative approval for Olopatadine Hydrochloride Ophthalmic Solution to treat itchy eyes

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.

Read also: Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ER

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News