Posted by Michael Wonder on 26 Oct 2021
Eyenovia announces reclassification of MydCombi as drug device combination product by FDA
25 October 2021 - Company received complete response letter with additional requests and is preparing necessary documents for expedited resubmission,
Eyenovia today announced that MydCombi, the company’s proprietary, first in class combination microdose formulation of tropicamide and phenylephrine for in office pupil dilation, has been reclassified as a drug device combination product by the U.S. FDA in a complete response letter for the company’s new drug application received on 22 October 2021.
