LYNX-2 Follows SPA Agreement with FDA Development of PS is Funded by Ocuphire's Partner Viatris FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc....
Viatris, a global healthcare company, announced the U.S. commercial launch of RYZUMVI (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholyticagents in the United States. RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation.
The FDA on Wednesday approved Viatris and Ocuphire’s Ryzumvi, also known as phentolamine ophthalmic solution, to treat pharmacologically-induced mydriasis, or dilation of the pupils. The partners plan to make Ryzumvi available in the U.S. in the first half of 2024, Viatris and Ocuphire said in a release.
Enforcement Report - Week of January 18, 2023
MD Pharmaceutical Supply, LLC Receives FDA Warning Letter
FARMINGTON HILLS, Mich., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of $3.1 million for the 505(b)(2) New Drug Application (NDA) for Nyxol (phentolamine ophthalmic solution), the Company’s late stage product candidate. Ocuphire remains on track to file the NDA for Nyxol in its first indication, reversal of mydriasis (RM), in late 2022.
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