14, Jun 2023
Granules India Limited Receives ANDA Approval for Levetiracetam Tablets in record 9 months
Hyderabad, 14 June 2023: Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets USP, 250 mg, 500 mg, 750 mg, and 1,000 mg. bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keppra Tablets of UCB, Inc. (UCB).
Levetiracetam Tablets are indicated as adjunctive therapy in the treatment of:
Partial onset seizures in adults and infants of age 1 month and older children with epilepsy;
Myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy
Primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Granules now has a total of 58 ANDA approvals from US FDA (56 Final approvals and 2 tentative approvals).
The current annual U.S. market for Levetiracetam Tablets is approximately $247 Million, according to MAT Mar 2023, IQVIA/IMS Health.