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
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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.
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