FDA Places Hold on Ocugen’s Investigational New Drug Application

Ocugen

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s 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 communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible.

COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

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