Business · 03/08/2011
FDA Proposes to Refuse Approval of Bromday Supplemental New Drug Application
The FDA is proposing to refuse approval of a supplemental new drug application for Bromday (bromfenac ophthalmic solution, 0.09%) in a 2.4 milliliter fill size, giving ISTA Pharmaceuticals an opportunity to request a hearing.
Original source language: Federal Register — Health and Human ServicesOpen original release →