A determination that the drug is the same may not be taken back
What the document says“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
Where the Secretary determines the drug is the same, that determination may not be changed or withdrawn after the abbreviated application is submitted, unless the listed drug's formulation has changed and the Secretary has found the prior formulation was withdrawn for reasons of safety or effectiveness, or the Secretary makes a written determination that an error has been identified. Where the second applies, the Secretary must give notice and a copy of the written determination to the requester.
What the document actually says“the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless--”
Once the health chief says the drug is the same, that answer stands. It may be taken back only in the cases named next.
A maker builds its plans on that answer. Pulling it back later would waste years of work. Two narrow exceptions remain.
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