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USFDA nod to Granules India Seizure drug Levetiracetam
Hyderabad: 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.
The product 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
• 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.
Read also: Granules India bags USFDA nod for Hypertension drug Metoprolol Succinate ER
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751