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Makes a number of revisions to Abbreviated New Drug Application (ANDA) labeling requirements to ensure that ANDAs with outdated labeling can be approved if the reference listed drug (RLD) was changed within 60 days of the event that cleared the way for generic competition and the generic sponsor agrees to submit a revised label within 60 days.
Prior to January 2013, as noted on the FDA website dedicated to a number of ACA provisions under the agency’s jurisdiction, the FDA “established a specialized approval letter to use in this circumstance so that FDA can approve the generic drug and permit the sponsor 60 days to revise the label according to the changes made in the RLD label. This specialized approval letter will not be used if the changes to the RLD label were related to certain safety information.” For more specific details, including key implementation milestone information, visit here.
SEC. 10609. LABELING CHANGES. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following: ‘‘(10)(A) If the proposed labeling of a drug that is the subject of an application under this subsection differs from the listed drug due to a labeling revision described under clause (i), the drug that is the subject of such application shall, notwithstanding any other provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if— ‘‘(i) the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph (5)(B)(iii), and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration; ‘‘(ii) the labeling revision described under clause (i) does not include a change to the ‘Warnings’ section of the labeling; ‘‘(iii) the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and ‘‘(iv) such application otherwise meets the applicable requirements for approval under this subsection. ‘‘(B) If, after a labeling revision described in subparagraph (A)(i), the Secretary determines that the continued presence in interstate commerce of the labeling of the listed drug (as in effect before the revision described in subparagraph (A)(i)) adversely impacts the safe use of the drug, no application under this subsection shall be eligible for approval with such labeling.’’.
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