FDA Grants 12-Year Exclusivity to Flublok
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has granted exclusivity to Flublok influenza vaccine for a period of 12 years. The regulatory exclusivity means that no product similar to Flublok can be approved by FDA before Jan. 16, 2025. Flublok is the first vaccine awarded this status. “The FDA’s designation prevents a generic product maker from capitalizing on the hard work of our team,” said Manon Cox, president and CEO of Protein Sciences Corp. “We are delighted that the FDA recognizes Flublok as a singular innovation in the prevention of an important and often deadly disease caused by the influenza virus.”
