According to Ocugen, their decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested additional information and data for full approval. The company also said it will need further clinical trials to submit a distribution request for Covaxin.
The company is working with Bharat Biotech of India to develop Covaxin for the US market.
Ocugen recently granted exclusive rights to market the vaccine in Canada and entered into negotiations with Health Canada for regulatory approval.
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Source: Portfolio.hu – Gazdaság by www.portfolio.hu.
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