"New Chemical Entity Exclusivity Determinations for Fixed-Combination Drug Products": Combo Drugs Now Eligible For 5-Year Exclusivity
The Food and Drug Administration (FDA) recently finalized guidance which allows fixed-combination drugs consisting of at least one new drug product to be eligible for a five-year “New Chemical Entity” (NCE) exclusivity period. FDA’s policy, entitled New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products, changes the Agency's previous interpretation that rendered combination products with even one “previously approved moiety” ineligible for five-year exclusivity. While this policy is good news for manufacturers of combination products going forward, FDA’s new guidance does not...
Source: Policy and Medicine - November 26, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
