MydCombi FDA Approval Status
Last updated by Judith Stewart, BPharm on Dec 30, 2020.
FDA Approved: No
Brand name: MydCombi
Generic name: phenylephrine and tropicamide
Dosage form: Ophthalmic Solution
Company: Eyenovia, Inc.
Treatment for: Pharmacologic Mydriasis
MydCombi (phenylephrine and tropicamide) is a fixed-combination microdose formulation of the approved mydriatics phenylephrine and tropicamide in development for pharmacologic mydriasis in the eye care practitioner’s office.
The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow. MydCombi is delivered by Eyenovia’s proprietary Optejet® dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application.Development Timeline for MydCombi
| Date | Article |
|---|---|
| Mar 2, 2021 | Eyenovia Announces FDA Acceptance of the MydCombi NDA |
| Dec 29, 2020 | Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi |
Further information
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