USFDA gives final approval for Seizure injections

Lacosamide Injection is used to treat partial-onset seizures.

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USFDA Approval
USFDA Approval

Last Updated on October 10, 2024 by The Health Master

Ahmedabad: Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Lacosamide Injection USP, 200 mg/20 mL (10 mg/mL) single-dose vials (US RLD: Vimpat).

Lacosamide Injection is used to treat partial-onset seizures.

It is also used with other medicines to treat primary generalized tonic-clonic seizures.

It acts on the central nervous system (CNS) to reduce the number and severity of seizures.

The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, India.

As per IQVIA MAT May 22, lacosamide injection has a market size of USD 50 million.

The group now has 316 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

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