Zydus Cadila gets FDA approval to market Vigabatrin Tablets 500mg
Zydus (Cadila Healthcare) has secured final approval from the US Food and Drug Administration (FDA) to market Vigabatrin Tablets in the strength of 500mg.
Vigabatrin Tablets is the generic version of Sabril Tablets. It is indicated in the US for the treatment of babies, aged one month to two years, having infantile spasms.
The drug is also used in combination with other medications for the treatment of seizure disorders (epilepsy).
According to Zydus, Vigabatrin reduces the frequency of seizures in adults and children who cannot control their seizures with other treatments.
Vigabatrin, which is an anticonvulsant, is known to function by preventing the breakdown of a natural calming substance (GABA) in the brain.
Zydus will manufacture the drug at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
The company now has 326 approvals and has to date filed more than 400 ANDAs since the start of the filing process in FY 2003-04.