Zydus receives final approval from US FDA for Vigabatrin tablets

Zydus has received final approval from the US Food and Drug Administration (FDA) to market Vigabatrin tablets in the strength of 500 mg, the company notified via a statement.

The statement mentioned that Vigabatrin is used to treat babies, one month to two years old with infantile spasms. It is also used in combination with other medications to treat seizure disorders (epilepsy). It decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment.

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, the statement further said.