Zydus obtains FDA nod for generic Sabril
The Food and Drug Administration has given Zydus its blessing for vigabatrin tablets in a dosage strength of 500 mg.
The medication is the generic of Sabril.
[Read more: Zydus Cadila gets tentative FDA OK for lenalidomide]
Vigabatrin is used to treat babies, one month to age 2 years old with infantile spasms.
It also is used in combination with other medications to treat seizure disorders (epilepsy). According to Zydus, Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatments.
Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain.
[Read More: Pfizer gets FDA OK for new Xeljanz indication]
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.