The drug maker said that it has received final approval from US Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500 mg.
The said drug is equivalent to reference listed drug, 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.
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya, Ahmedabad (India).
Vigabatrin for Oral Solution USP, 500 mg had annual sales of $233.7 million in the United States (IQVIA MAT Dec. 2022).
As on 31 December 2022, the Zydus group now has 349 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus Lifesciences is engaged in an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The product portfolio of the company includes active pharmaceutical ingredients [API] and human formulations.
The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.
Shares of Zydus Lifesciences were up 0.61% to Rs 475.70 on the BSE.
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