Comment
Author: Admin | 2025-04-28
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted under subsection (b) for a non-racemic drug containing as an active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) a single enantiomer that is contained in a racemic drug approved in another application under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active moiety as that contained in the approved racemic drug, if—(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and(ii) the application submitted under subsection (b) for such non-racemic drug—(I) includes full reports of new clinical investigations (other than bioavailability studies)—(aa) necessary for the approval of the application under subsections (c) and (d); and(bb) conducted or sponsored by the applicant; and(II) does not rely on any clinical investigations (other than bioavailability studies) that are part of an application submitted under subsection (b) for approval of the approved racemic drug; and(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for approval of a condition of use—(i) in a therapeutic category in which the approved racemic drug has been approved; or(ii) for which any other enantiomer of the racemic drug has been approved.(2) Limitation(A) No approval in certain therapeutic categoriesUntil the date that is 10 years after the date of approval of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph, the Secretary shall not approve such non-racemic drug for any condition of use in the therapeutic category in which the racemic drug has been approved.(B) LabelingIf applicable, the labeling of a non-racemic drug described in paragraph (1) and with respect to which the applicant has made the election provided for by such paragraph shall include a statement that the non-racemic drug is not approved, and has not been shown to be safe and effective, for any condition of use of the racemic drug.(3) Definition(A) In generalFor purposes of this subsection, the term "therapeutic category" means a therapeutic category identified in the list developed by the United States Pharmacopeia pursuant to section 1395w–104(b)(3)(C)(ii) of title 42 and as in effect on September 27, 2007.(B) Publication by SecretaryThe Secretary shall publish the list described in subparagraph (A) and may amend such
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