Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection, Infusion Bags

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), 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 IQVIATM (IMS Health), Levetiracetam in Sodium Chloride Injection had US sales of approximately $19 million for the 12-month period ending November 2024.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 2204.60 as compared to the previous close of Rs. 2242.50. The total number of shares traded during the day was 5872 in over 709 trades.

The stock hit an intraday high of Rs. 2244.00 and intraday low of 2182.10. The net turnover during the day was Rs. 13006249.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 CaplinSterlies FinalApproval USFDA ANDA Levetiracetam SodiumChlorideInjection