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The record reflects FDA's reasoned decision-making in rejecting Biovail's argument that ANDA applicants must meet criteria in addition to the requirements set forth by FDA to demonstrate that a generic version of Wellburin XL is bioequivalent to Wellb7trin XL, the RLD. In relying on its scientific and technical expertise, the agency acted reasonably when it used its long-standing, well-established, and scientifically based bioequivalence criteria to approve Anchen's ANDA. Biovail has failed to show that FDA was arbitrary and capricious in.
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