Bharat Biotech won't seek emergency nod for Covaxin in US, to apply for full approval
Bharat Biotech’s American partner Ocugen has dropped the plan to seek an emergency approval for the coronavirus jab based on a recommendation from the US FDA.
June 11, 2021 / 08:39 AM IST
Ocugen is co-developing Covaxin with Hyderabad-based Bharat Biotech for the US market.
The US launch of Bharat Biotech’s Covaxin is likely to be delayed as the Hyderabad-based company’s American partner Ocugen has dropped the plan to seek an emergency approval for the coronavirus jab.
Ocugen has said it will now seeking a full approval, that is pursue a biologics licence application (BLA), on the recommendation of the US drug regulator.
“Although we were close to finalizing our EUA (emergency use authorisation) application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Ocugen CEO and co-foundrr Dr Shankar Musunuri said in a statement on June 10.
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The Food and Drug Administration also requested additional information and data. Ocugen was in discussions with the FDA to understand the information required to support a BLA submission, the company said.
Ocugen is co-developing Covaxin with 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.Click here for Moneycontrol's full coverage of COVID-19