; (C) excludes such an application or supplement to an application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) that has been granted New Chemical Entity exclusivity ( 21 U.S.C. 355(c)(3)(E)(ii) ) by the Food and Drug Administration; and (D) excludes such an application or supplement submitted under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) that has been granted exclusivity pursuant to section 351(k)(7) of such Act ( 42 U.S.C. 262(k)(7) ). (5) Commission The term Commission means the Federal Trade Commission (6) Disadvantage The term disadvantage means to impede the listed drug or reference product’s ability to compete on the merits with the follow-on product. This term excludes actions that consist solely of— (A) truthful, non-misleading promotional marketing; or (B) ceasing promotional marketing for the listed drug or reference product. (7) Generic drug The term generic drug means a drug approved under an application submitted under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). (8) Listed drug The term listed drug means a drug listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ). (9) Manufacturer The term manufacturer means the holder, licensee, or assignee of— (A) an approved application for a drug under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) )