USFDA approves Zydus Lifesciences Infantile spasm drug Vigabatrin

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.

Published On 2023-03-04 05:40 GMT   |   Update On 2023-03-04 05:40 GMT
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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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The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad (India).

Medical Dialogues team had earlier reported that the company had received final approval from the USFDA to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Qudexy XR Extended-Release capsules).

Read also: USFDA nod to Zydus Lifesciences Migraine drug Topiramate Extended Release

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States (IQVIA MAT Dec. 2022). The group now has 349 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences cold sores cream Acyclovir bags USFDA okay

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.

Read also: Zydus Lifesciences bags USFDA nod for Apixaban Tablets to treat blood clots in veins of legs or lungs

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