The US Food and Drug Administration (FDA) has rejected Ocugen's application for an emergency use authorization (EUA) of Covaxin. Bharat Biotech's US partner on June 10 said it would no longer pursue an emergency use authorization for Covaxin, and would instead aim to file for a full US approval of the anti-COVID shot.
Ocugen said the decision was based on a recommendation from the US FDA, which also requested more information and data for full approval.
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The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
"Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a biologics license application (BLA) path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Ocugen CEO, said in a statement.
Ocugen is co-developing Covaxin with Hyderabad-based Bharat Biotech for the US market.
The company also recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval.
Ocugen in a regulatory filing said it has agreed to pay another $10 million to Bharat Biotech within a month from the commercial launch of Covaxin in the North American country.
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