FDA accepts new drug application for glaucoma treatment
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The FDA has accepted a new drug application for PDP-716 for the treatment of glaucoma, according to a press release from Visiox Pharma.
“The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716,” Ryan Bleeks, CEO of Visiox Pharma, said in the release. “If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals.”
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The Prescription Drug User Fee Act target action date for PDP-716 (0.35% brimonidine tartrate) is Aug. 4, 2023.
The company also plans to submit a second NDA to the FDA for SDN-037 to address “an unmet need for cataract surgery,” the release said.
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