Zydus secures USFDA approval for infantile spasm drug

Zydus secures USFDA approval for infantile spasm drug

The group now has 349 approvals and has so far filed over 440 Abbreviated New Drug Applications.

FPJ Web DeskUpdated: Friday, March 03, 2023, 05:12 PM IST
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(PTI Photo)

Through a regulatory filing, Indian pharma major Zydus has informed that it has received USFDA's approval for Vigabatrin for Oral Solution USP, 500 mg. The drug is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older.

Clocking robust sales in the US

It also treats infantile spasms in babies and children between the ages of 1 month and 2 years. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya in Gujarat's Ahmedabad. Vigabatrin for Oral Solution USP, 500 mg had annual sales of $233.7 million in the United States.

The group now has 349 approvals and has so far filed over 440 Abbreviated New Drug Applications since the commencement of the filing process in FY 2003-04.

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