Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Bl...
Osmotica Pharmaceuticals plc - Ordinary Shares (OSMT)
Last osmotica pharmaceuticals plc - ordinary shares earnings: 3/18 04:05 pm
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Source: GlobeNewswire
BRIDGEWATER, N.J., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company) today announced that the Company received notification that the New Drug Application (“NDA”) for RVL-1201 (“RVL”) for Acquired Blepharoptosis (droopy eyelid or ptosis) has been filed by the U.S. Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (PDUFA) goal date of July 16, 2020. “We are delighted that our NDA has been accepted for filing. Today, there are no pharmacologic options approved for treatment of droopy eyelid. If approved, RVL would offer physicians and patients a therapeutic option for the treatment of ptosis supported by compelling safety and efficacy data from three well-controlled pivotal studies. With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired ble
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