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City Solution / / Company Ames / Applicant Vistakon Pharmaceuticals LLC / / Country United States / / Event FDA Phase / / Facility Laboratory Findings / / IndustryTerm ophthalmic solution / alcaftadine ophthalmic solution / drug product / 0phthalmic solution / instillation site / / MedicalCondition both ocular itching / sore throat / keratitis / ocular diary itching / mouse lymphoma assay / disease / headache / nasopharyngitis / hyperemia / ocular itching / nausea / pruritis / rhinitis / itching / seasonal allergic conjunctivitis / eye irritation / allergic conjunctivitis / eye pruritus / fatigue / eye pain / sinusitis / cough / influenza / cold/flu / / Organization Division of Scientific Investigations / PDUFA Goal Date Division / Pediatric Research and Equity Act Waivers Committee / Equity Act Waivers Committee / Advisory Committee / / Person Martin P. Nevitt / Martin P Nevitt / / Product Pataday / Alamast / Acular / F-5525 / F-3730 Formulation / edetate disodium / sodium chloride / Alocril / Optivar / Elestat / H3C / F-3730 / / PublishedMedium the DSI review / the Pediatric Research / the Pharm/Tox review / / Technology Pharmacokinetics / API / Pharmacodynamics / /
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