Covaxin Bharat Biotech applies for US FDA approval
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Hyderabad Ocugen, Bharat Biotech's American partner for Covid-19 vaccine Covaxin, has submitted a 'Master File' to the US Food and Drug Administration prior to seeking an emergency use authorisation in that country.
"The company is currently evaluating the clinical and regulatory path for Covaxin in the United States including obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Also, eventually biologic license application (BLA) approval in the United States, as well as the company's commercialization strategy, if authorized or approved," Ocugen has said in a recent regulatory filing.
Ocugen has submitted key information and data to date including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review and input prior to a planned EUA submission.
