Zydus receives final USFDA approval for Vigabatrin tablets

Vigabatrin is used to treat babies, one month to 2 years old with infantile spasms

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Zydus
Zydus receives final approval from USFDA for Vigabatrin Tablets.

Ahmedabad, India, 20 January 2022, Zydus has received final approval from the USFDA to market Vigabatrin Tablets in the strength of 500 mg (US RLD – Sabril Tablets). Vigabatrin is used to treat babies, one month to 2 years old with infantile spasms. It is also used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatments. Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 326 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in the financial year 2003-04.

Zydus is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is dedicated ton creating healthier communities globally.

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