PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|July 30, 2013
FDA Grants Priority Review to Mallinckrodt's MNK-795
Author(s)Pharmaceutical Technology Editors
Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.
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The NDA acceptance triggers a $5-million milestone payment to Depomed under a license agreement between Depomed and Mallinckrodt. Depomed is also entitled to an additional milestone payment upon approval of the NDA and high single digit royalties on net sales of MNK-795, if approved.
FDA granted the NDA a priority review, a designation given to drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications.
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