FDA approves efficacy supplement for Famygen's Ryzumvi eye drops
The FDA approved a supplemental efficacy application for phentolamine mesylate ophthalmic solution Ryzumvi on October 16, 2026.
The FDA approved a supplemental application for Ryzumvi, an ophthalmic solution containing phentolamine mesylate, with a status date of 2026-10-16. The product is listed under application number NDA217064, with sponsor Famygen Life Sci.1
The submission was classified as an efficacy supplement, numbered submission 5, and was reviewed under standard priority.1 The drug is formulated as a solution given by the ophthalmic route, with phentolamine mesylate present at a strength equivalent to 0.75% base.1
The FDA record marks the submission status as approved (AP). The filing does not include additional detail on the specific indication, clinical data, or label changes associated with this supplement. No further milestones or regulatory next steps are specified in the available record.
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