Ocugen to apply for full US FDA approval of Covaxin, not for EUA
Ocugen said the decision was based on a recommendation from the US FDA, which also requested more information and data for full approval
Ocugen said it would no longer pursue an emergency use authorisation for its COVID-19 vaccine candidate, Covaxin, and would instead aim to file for a full US approval of the shot.
Ocugen said the decision was based on a recommendation from the US Food and Drug Administration (FDA), which also requested more information and data for full approval.
The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
“While this will extend our timelines, we are committed to bringing COVAXIN to the U.S.,” Ocugen Chief Executive Officer Dr Shankar Musunuri said.
The company is co-developing Covaxin with India-based Bharat Biotech for the US market.
Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.
(Edits by EP News Bureau)