Zydus receives final approval from USFDA for Vigabatrin Tablets
NEW DELHI: Zydus has received final approval from the USFDA to market Vigabatrin Tablets in the strength of 500 mg (US RLD: Sabril Tablets). Vigabatrin is used to treat babies, one month to 2 years old with infantile spasms.
It is also used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin 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 group now has 326 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.