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Clinical research / Design of experiments / Non-steroidal anti-inflammatory drugs / Amines / Antihistamines / Azelastine / Olopatadine / Conjunctivitis / Clinical trial / Chemistry / Health / Organic chemistry


22134 Alcaftadine Clinical PREA
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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 / /

SocialTag