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Caplin Point’s arm gets USFDA’s approval for Levetiracetam in Sodium Chloride Injection, infusion bags

17 Jan 2025 Evaluate

Caplin Point Laboratories’ Subsidiary--Caplin Steriles 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 in the treatment of partial-onset seizures in adults with epilepsy, in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy and 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. 

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


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