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Non-steroidal anti-inflammatory drugs / Amines / ISTA Pharmaceuticals / Azelastine / Olopatadine / Norfloxacin / Ketorolac / Regulatory requirement / Clinical trial / Chemistry / Organic chemistry / Organochlorides


022288_Bepotastine_Clinical_PREA
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Company

ISTA Pharmaceuticals Inc. / Tanabe Seiyaku Co. Ltd. / Applicant Ista Pharmaceuticals Inc. / Mitsubishi Tanabe Pharma Corporation / Ube Industries Ltd. / /

Country

Japan / United States / /

Event

FDA Phase / Product Issues / Product Recall / /

Facility

SPA Meeting / Laboratory Findings / /

IndustryTerm

ophthalmic solutions / ophthalmic solution / treatment / parallel-group study besilate ophthalmic solution / bepotastine besilate solutions / drug product / besilate ophthalmic solution / investigational product / investigational products / bepotastine besilate ophthalmic solution / /

MedicalCondition

sore throat / neoplasms / keratitis / ocular inflammation / headache / CAC-induced allergic conjunctivitis / hyperemia / ocular itching / inflammatory sites / nausea / pruritis / rhinitis / itching / allergic conjunctivitis / fatigue / urticaria / allergic rhinitis / eye pain / pruritus/itching / sinusitis / cough / cold/flu / skin diseases / /

Organization

Advisory Committee / MD NDA / /

Person

Bergmann / Macejko / Michaelson / Dao / Kurata / Sonal D. Wadhwa / Torkildsen / /

Position

Major / Clinical Investigator / /

Product

CL / Overdose / Pataday / Alamast / Acular / Talion / Sodium chloride / Alocril / Optivar / Elestat / Consideration / Japanese oral / Japan / SAF0405071 / /

Technology

Pharmacokinetics / Pharmacodynamics / /

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