FDA denies emergency use nod for Covaxin in US, Well being Information, ET HealthWorld

New Delhi: The US Meals and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has requested for added information, biopharmaceutical Ocugen, the US companion of the Indian vaccine maker has stated.

FDA beneficial that Ocugen “pursue a Biologics Licence Utility (BLA) submission as an alternative of an EUA application” and “requested extra data and information”. Ocugen anticipates that information from extra scientific trials might be wanted to assist the submission. “We have been near finalising our EUA application after we obtained (FDA’s) suggestion to pursue a BLA path. Whereas this may prolong our timelines, we’re dedicated to bringing Covaxin to the US,” stated Ocugen’s Shankar Musunuri. businesses

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