RAPS: New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called \"New Chemical Entity\" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively.