Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited (BSE: CAPPL, NSE: CAPLIPOINT), has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam in Sodium Chloride Injection. The product is available in three strengths: 500mg/100mL, 1000mg/100mL, and 1500mg/100mL infusion bags, which are classified as Large Volume Parenterals (LVP).
Levetiracetam in Sodium Chloride Injection is a generic therapeutic equivalent of the Reference Listed Drug (RLD) from HQ Specialty Pharma Corp. This approval marks Caplin Steriles’ second Ready-To-Use (RTU) Infusion Bag product to be approved by the USFDA. The company currently has six additional RTU products under review with the FDA.
Levetiracetam is an antiepileptic medication used 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 (IMS Health), Levetiracetam in Sodium Chloride Injection generated approximately $19 million in US sales over the 12-month period ending November 2024.