Zydus Lifesciences gets final approval from USFDA for Lacosamide Injection

30 Jun 2022 Evaluate

Zydus Lifesciences 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.

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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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