Examples of NDA in a sentence
The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
The NDA submission lacks data on concomitant antipsychotic administration.
Pursuant to the terms of the license, Supemus also granted to Apotex a selective and limited waiver of any unexpired periods of pediatric and/or other statutory or regulatory exclusivities that might be listed in the Orange Book in connection with NDA No. 202810 with respect to the above-referenced ANDA No. 213369 held by Apotex Inc.
Supernus hereby selectively waives its right to any unexpired periods of pediatric and/or other statutory or regulatory exclusivities listed in connection with NDA No. 202810, solely to the extent necessary to enable the approval of ANDA No. 213369 for oxcarbazepine extended release tablets.