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Bharat Biotech's Covaxin rejected for emergency use authorization by U.S FDA
Posted
June 11, 2021
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516
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June 11, 2021
516
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2:55Now PlayingU.S Food and Drug Administration has rejected the emergency use authorization for Covaxin and instead suggested going for Biologics License Application. Now Ocugen INC, the U.S partner of Bharat Biotech's Covaxin is not preparing to submit the Biologics License Application which is the full approval mechanism by the FDA for drugs and vaccines. The new development will result in the delay of the Covaxin launch in the United States. Though this will not affect India in any way, the longer route has been suggested by the United States. Emergency use approval is not coming through from the U.S FDA for covaxin.
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