Caplin Point Subsidiary, Caplin Steriles, Receives USFDA Approval for Levetiracetam in Sodium Chloride Injection

Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its ANDA Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags. This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles, with a further 6 products under review with FDA for RTU Bags segment. Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. According to IQVIA™, Levetiracetam in Sodium Chloride Injection had US sales of approximately $19 million for the 12-month period ending November 2024.