Last Updated on October 10, 2024 by The Health Master
New Delhi: Granules India Limited announced that its Levetiracetam Tablets have been received ANDA approval from US Food and Drugs Administration (USFDA).
The ANDA approval is for 250 mg, 500 mg, 750 mg, and 1,000 mg equivalent tablets.
The medication indicated as adjunctive therapy is 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 and primary generalised tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
With this, the company now has a total of 58 ANDA approvals from USFDA. Out of which 56 are Final approvals and the rest are tentative approvals.
According to MAT Mar 20233, IQVIA / IMS Health, the current annual US market for Levetiracetam Tablets is approximately $247 million.
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