Caplin Steriles gets USFDA nod for Levetiracetam in Sodium Chloride Injection, infusion bags

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-01-17 09:38 GMT | Update On 2025-01-17 09:38 GMT

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.

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 Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited, has developed and filed 45 ANDAs in USA on its own and with partners, with 31 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, South Africa etc.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Caplin Steriles gets USFDA nod for Levetiracetam in Sodium Chloride Injection, infusion bags

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