No emergency use approval for Bharat Biotech's Covaxin in US, FDA seeks more info & data
- 3 years ago
The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its Covid-19 vaccine, delaying the company’s vaccine launch in that country.
Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin. This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval.
Ocugen, the US partner of Bharat Biotech, on Thursday said the company will now be seeking a full approval of Covaxin. This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval.