Approval

Zydus Receives Final Approval From USFDA For Vigabatrin Tablets

January 21,2022 10:18 AM
- By Admin

Vigabatrin is used to treat one month to two-year-old babies with infantile spasms. It is also used in combination with other medications to treat seizure disorders.

Zydus received final approval from the USFDA to market Vigabatrin tablets in the strength of 500 mg. Vigabatrin tablets are the generic bioequivalent of the reference listed drug sabril tablets. Vigabatrin is used to treat one month to two-year-old babies with infantile spasms. It is also used in combination with other medications to treat seizure disorders (epilepsy). Tablets decreases the number of seizures in adults and children who have not been able to control their seizures with other treatments. It is an anticonvulsant 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 in Ahmedabad. Zydus group now has 326 approvals to its name and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.