Pub. L. 112-144, tit. XI, subtit. A, sec. 1101 (as amended)
REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
(a) In General.—Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended by striking “2012” and inserting “2017”.
(b) Amendment.—Section 505(u)(1)(A)(ii)(II) (21 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by inserting “clinical” after “any”.