FDA grants final approval for infantile spasm drug

The FDA has granted final approval to Zydus for Sabril, an anticonvulsant used to treat children aged 1 month to 2 years with infantile spasms.

Sabril (vigabatrin), which works by stopping the breakdown of a natural calming substance (GABA) in the brain, was approved in 500 mg tablet form. It can be used alongside other medications to treat seizure disorders.

The drug will be manufactured at the Zydus formulation facility in Ahmedabad, India.