USFDA nod to Zydus Lacosamide Injection for partial-onset seizures

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

Published On 2022-07-01 06:04 GMT   |   Update On 2022-07-01 06:04 GMT

Ahmedabad: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), has recently announced that the company 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.

Medical Dialogues team had earlier reported that Zydus had received final approval from the US health regulator to market its generic version of Vigabatrin tablets to treat babies with infantile spasms and epilepsy in combination with other medications.

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.

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