Caplin Steriles gets USFDA nod for Levetiracetam in Sodium Chloride Injection, infusion bags
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by 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.
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