Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.

  • By IPP Bureau | July 01, 2022

Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare 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 injectables manufacturing facility at Jarod, India. Lacosamide Injection has a market size of USD 50 mn (as per IQVIA MAT May 22).

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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