Ocugen (OCGN) announces FDA has issued clinical hold on IND to evaluate the COVID-19 vaccine candidate, COVAXIN

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Go back to Ocugen (OCGN) announces FDA has issued clinical hold on IND to evaluate the COVID-19 vaccine candidate, COVAXIN

Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)

November 26, 2021 7:01 AM EST

MALVERN, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Companys Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN outside the United States.

The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies. The Company expects to receive formal written... More