Caplin Point Laboratories receives USFDA approval for Levetiracetam in Sodium Chloride Injection

Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags (Large Volume Parenteral), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from HQ Speciality Pharma Corp. 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 i) in the treatment of partial-onset seizures in adults with epilepsy, ii) in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy and iii) in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.

 

According to IQVIA (IMS Health), Levetiracetam in Sodium Chloride Injection had US sales of approximately $19 million for the 12-month period ending November 2024.

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