Granules India receives ANDA nod for Levetiracetam Tablets by admin- Wednesday, June 14th, 2023 04:11:30 PM
Granules India introduced that the United States Food & Drug Administration (USFDA) has authorized 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 inside the remedy of:
Partial onset seizures in adults and infants of age 1 month and older children with epilepsy;
Myoclonic seizures in adults and youngsters 12 years of age and older with juvenile myoclonic epilepsy
Primary generalized tonic-clonic seizures in adults and kids 6 years of age and older with idiopathic generalized epilepsy.
Granules now has a total of fifty eight ANDA approvals from USFDA (fifty six Final approvals and a couple of tentative approvals).
The modern-day annual US marketplace for Levetiracetam Tablets is approximately $247 Million, according to MAT Mar 2023, IQVIA/IMS Health.