‘(1) IN GENERAL- Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, direct or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.CommentsClose CommentsPermalink
‘(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; andCommentsClose CommentsPermalink
OpenCongress allows anyone to follow legislation in Congress, from bill introduction to floor vote. Learn more about issues you care about and connect with others who share similar views.
OpenCongress was founded by the Participatory Politics Foundation in 2007 and operated as a joint project with the Sunlight Foundation until May 2013.
OpenCongress' data was updated about 12 hours ago.
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