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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...
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).
Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatments.
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.