USFDA nod to Zydus to market generic version of Vigabatrin

Written by Dr. Divya Colin Published On 21 Jan 2022 10:32 AM | Updated On 21 Jan 2022 10:32 AM

USFDA nod to Zydus to market generic version of Vigabatrin

The approval by the US Food and Drug Administration is for Vigabatrin tablets of 500 mg strength, Cadila Healthcare said in a regulatory filing.

New Delhi: Cadila Healthcare on Thursday said group firm Zydus has received final approval from the US health regulator to market its generic version of Vigabatrin tablets to treat babies with infantile spasms and epilepsy in combination with other medications.

The approval by the US Food and Drug Administration is for Vigabatrin tablets of 500 mg strength, Cadila Healthcare said in a regulatory filing.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added. The company said 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).

Also Read:Zydus gets USFDA nod to Pimavanserin for Parkinson's disease-linked psychosis

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 group now has 326 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Also Read:Zydus Cadila Announces COVID-19 Vaccine Expansion Plan to Multiple Countries With Korean Firm

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Source : PTI

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.