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FDA Approves First-line Use for Allergan Glaucoma Drug

[ Price : $8.95]

FDA approves Allergans Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for reducing elevated int...

FDA Clears InfraReDx Coronary Imaging System

[ Price : $8.95]

FDA clears an InfraReDx 510(k) for the LipiScan IVUS Coronary Imaging System, a cardiac catheter intended to help cardiologists id...

FDA Denies Petition on Testing of Emergency Products

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FDA denies a citizen petition asking it to develop testing methods for products to be used by lay individuals in emergency situati...

FDA 'Orphan' Status for Pulmonary Fibrosis Drug

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FDA grants Stromedix an orphan drug designation for STX-100, indicated for treating idiopathic pulmonary fibrosis.

Repeat Aralast Ad Violations Raised

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CBER warns Baxter Healthcare of continuing promotional materials violations for its Aralast NP.

FDA Wants Advice on Dextromethorphan Abuse Potential

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FDA asks the Drug Safety and Risk Management Advisory Committee for advice on ways to curb increasing dextromethorphan abuse.

FDA Launches FDA-Track Performance Measure

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FDA launches FDA-TRACK, a performance monitoring and measurement system that it says will be available to the public.

FDA Approves Reckitt Benckiser Opiod Dependence Drug

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FDA approves a Reckitt Benckiser Pharmaceuticals NDA for Suboxone (buprenorphine HCl/naloxone HCl dihydrate) sublingual film, indi...

FDA Extends Seizure Drug Review Over REMS

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FDA extends by 90 days its review of a Valeant Pharmaceuticals NDA for Potiga (ezogabine) in order to review a recently requested ...

FDA Bars Chinese Eyeglasses

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FDA cracks down on Chinese eyeglass imports that fail to meet required impact-resistance tests, after finding 38-100% broke comple...