Ocoven is applying for full U.S. approval for the Covaxin vaccine


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.

Cover image source: Getty Images


Source: Portfolio.hu – Gazdaság by www.portfolio.hu.

*The article has been translated based on the content of Portfolio.hu – Gazdaság by www.portfolio.hu. If there is any problem regarding the content, copyright, please leave a report below the article. We will try to process as quickly as possible to protect the rights of the author. Thank you very much!

*We just want readers to access information more quickly and easily with other multilingual content, instead of information only available in a certain language.

*We always respect the copyright of the content of the author and always include the original link of the source article.If the author disagrees, just leave the report below the article, the article will be edited or deleted at the request of the author. Thanks very much! Best regards!