From DCAT Value Chain Insights (VCI)
FDA has issued a draft guidance to specify a change in the agency’s interpretation of the five-year new chemical entity (NCE) exclusivity provisions as they apply to certain fixed-combination drug products (fixed-combinations). Historically, FDA has interpreted these provisions such that a fixed-combination was ineligible for five-year NCE exclusivity if it contained a previously approved active moiety, even if the product also contained a new active moiety (i.e., an active moiety that the agency had not previously approved).
In issuing the draft guidance, FDA noted that it recognizes that fixed-combinations have become increasingly prevalent in certain therapeutic areas (including cancer, cardiovascular, and infectious disease) and that these products play an important role in optimizing adherence to dosing regimens and improving patient outcomes. As a result, in the draft guidance FDA is revising its historical interpretation of the five-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products. If the new interpretation is adopted, FDA intends to apply the new interpretation prospectively, so the guidance, if finalized, would not apply to fixed-combination drug products that were approved prior to adopting the new interpretation.
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