Ocugen said the decision was based on a recommendation from the U.S. 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 U.S. market.
Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.
The company’s shares were down about 40% at $5.56 before the bell.