USFDA approves Zydus Lifesciences Infantile spasm drug Vigabatrin
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.
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Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500 mg (USRLD: Sabril for Oral Solution).
Vigabatrin for oral solution is indicated for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older. It is also used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.
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