US FDA approves Bharat Biotech’s Covaxin for clinical trails

The US Food and Drug Administration has lifted the clinical hold on Bharat Biotech’s Covaxin.

The US Food and Medication Administration (FDA) has withdrawn its clinical hold on Ocugen, Inc’s investigational new drug application to investigate the COVID vaccine candidate, BB152, also known as Covaxin outside the US, according to a statement from Bharat Biotech.

In the United States, Bharat Biotech’s Covaxin will be examined as a COVID vaccination candidate, the firm announced on Saturday. In the United States and Canada, Ocugen is co-developing Bharat Biotech’s Covaxin vaccination for COVID

According to a source at Bharat Biotech, “we now have the approval to begin human clinical trials for Covaxin in the United States.” Ocugen filed an IND with the FDA for a Phase-iii bridging study in support of a BLA (Biologics License Application) application, according to a filing with the US Securities and Exchange Commission (SEC). (A BLA is a document that asks for approval to bring a biologic product into interstate commerce.)

“In response to the notice of inadequacies, a thorough response has been filed to Health Canada (a Canadian department responsible for national health policy).” Liminal BioSciences has also signed a Letter of Intent for the acquisition of a new manufacturing site in Canada,” the company added.

 

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