Mealey's (September 17, 2020, 1:54 PM EDT) -- WASHINGTON, D.C. — In a Sept. 15 opinion, a federal judge in the District of Columbia indicated that although he agrees that new chemical entity (NCE) exclusivity status does not bar the U.S. Food and Drug Administration from approving a competing drug, the FDA's approval of "Numbrino" ran afoul of timelines prescribed by federal law (Genus Lifesciences Inc. v. Alex M. Azar, et al., No. 20-211, D. D.C., 2020 U.S. Dist. LEXIS 168370)....