In recognition of the increasingly important role fixed-combination products play in treating cancer, cardiovascular, and infectious diseases, FDA issued draft guidance in February that significantly departs from its historical interpretation of the five-year New Chemical Entity ("NCE") exclusivity provision. 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). The new draft guidance focuses on FDA's evolving interpretation of the term "drug" in the eligibility clause of the five-year NCE exclusivity statutory provisions to improve incentives for producing new drugs in fixed-combinations, a practice that is often safer and more effective. For more on this topic, read the Jones Day Alert and Law 360 article.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
