Granules India gets FDA approval for generic epilepsy drug Levetiracetam

Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets USP, in 250 mg, 500 mg, 750 mg, and 1,000 mg strengths.

The drug, bioequivalent and therapeutically equivalent to UCB, Inc.’s reference listed drug (RLD), Keppra Tablets, is used as an adjunctive therapy in the treatment of various forms of epilepsy.

Levetiracetam Tablets are indicated for treating partial onset seizures in adults and infants aged one month and older, myoclonic seizures in adults and adolescents aged 12 and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children aged six and older with idiopathic generalized epilepsy.

This approval brings Granules’ total to 58 ANDA approvals from the FDA, including 56 final approvals and 2 tentative approvals. According to data from IQVIA/IMS Health, the current annual US market for Levetiracetam Tablets is approximately $247 million, indicating a substantial opportunity for Granules India.