In a statement on Thursday, OcuGen said it would file a BLA for Covaccine as advised by the FDA. BLA is the FDA’s “Full Approval” mechanism under which drugs and vaccines are approved.
Hyderabad. Bharat Biotech of covid-19 vaccine covaccine In a setback to the US, the US food and drug regulator has advised its US partner OcuGen Inc to request the biological license application (BLA) route with additional data to gain approval for use of the Indian vaccine. In a statement on Thursday, OcuGen said it would file a BLA for Covaccine as advised by the FDA. BLA is the FDA’s “Full Approval” mechanism under which drugs and vaccines are approved. In such a situation, it may take some more time for the vaccine to get US approval. OcuGen said, “The company will no longer seek emergency access permission (EUA) for the vaccine.
The FDA has given a response to the master file to Okuzane. It has been advised that OcuGen should file a BLA request instead of an EUA application for its vaccine. In addition, a request has been made for some additional information and data.” OcuGen said this could delay the launch of Covaccine in the US. OcuGen is in discussions with the FDA to understand the additional information required for the BLA request. The company anticipates that an additional clinical trial data will be needed for the application to be approved. “While we are very close to finalizing our EUA application, the FDA has advised us to make the request through the BLA,” said Shankar Musunuri, CEO and Co-Founder of OcuGen. It will take longer, but we are committed to bringing the vaccine to the US.
Disclaimer:Prabhasakshi has not edited this news. This news has been published from PTI-language feed.