PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2461
between the drug and the listed drug in safety and therapeutic effect.’’. (b) EFFECT OF AMENDMENT.—The amendment made by subsection (a) does not alter the standards for approval of drugs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
21 USC 355 note.
SEC. 1104. CONFORMING AMENDMENTS.
Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended— (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by striking ‘‘(j)(5)(D)(ii)’’ each place it appears and inserting ‘‘(j)(5)(F)(ii)’’; (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by striking ‘‘(j)(5)(D)’’ each place it appears and inserting ‘‘(j)(5)(F)’’; and (3) in subsections (e) and (l), by striking ‘‘505(j)(5)(D)’’ each place it appears and inserting ‘‘505(j)(5)(F)’’.
Subtitle B—Federal Trade Commission Review SEC. 1111. DEFINITIONS.
21 USC 355 note.
In this subtitle: (1) ANDA.—The term ‘‘ANDA’’ means an abbreviated drug application, as defined under section 201(aa) of the Federal Food, Drug, and Cosmetic Act. (2) ASSISTANT ATTORNEY GENERAL.—The term ‘‘Assistant Attorney General’’ means the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice. (3) BRAND NAME DRUG.—The term ‘‘brand name drug’’ means a drug for which an application is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act, including an application referred to in section 505(b)(2) of such Act. (4) BRAND NAME DRUG COMPANY.—The term ‘‘brand name drug company’’ means the party that holds the approved application referred to in paragraph (3) for a brand name drug that is a listed drug in an ANDA, or a party that is the owner of a patent for which information is submitted for such drug under subsection (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic Act. (5) COMMISSION.—The term ‘‘Commission’’ means the Federal Trade Commission. (6) GENERIC DRUG.—The term ‘‘generic drug’’ means a drug for which an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act is approved. (7) GENERIC DRUG APPLICANT.—The term ‘‘generic drug applicant’’ means a person who has filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. (8) LISTED DRUG.—The term ‘‘listed drug’’ means a brand name drug that is listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act. SEC. 1112. NOTIFICATION OF AGREEMENTS.
21 USC 355 note.
(a) AGREEMENT WITH BRAND NAME DRUG COMPANY.—
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