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All Dermatend Lots Recalled

[ Price : $8.95]

FDA says that Solace International is recalling all lots of its Dermatend Original and Ultra in all sizes and dosage forms.

FDA Approves, Denies Parts of Teva Rescue Inhaler Petition

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FDA approves in part and denies in part a Teva April petition asking for a series of agency actions on metered-dose inhalers with ...

CDER Completes Reorganization to Focus on Drug Shortages

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CDER completes a reorganization intended to sharpen the Centers focus and strengthen its resources.

Salix Re-files sNDA for Xifaxan

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Salix Pharmaceuticals files a response to a 2011 FDA complete response letter that rejected a supplemental NDA for Xifaxan (rifaxi...

House Committee Initiative Mulls Off-label Dissemination Changes

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House Energy and Commerce Committee 21st Century Cures initiative leaders show interest in how companies communicate off-label inf...

FDA Accepts NDA for Actavis IBS Drug

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FDA accepts an Actavis NDA for eluxadoline, indicated for treating diarrhea and abdominal pain in men and women with diarrhea pred...

Illinois Compounding Pharmacy Recalls Sterile Preparations

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FDA says Martin Avenue Pharmacy is recalling all compounded sterile preparations due to a risk to sterility assurance.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Blanc du Blanc, Carousel Solutions, I''m a Little Teacup, Iradimed Corp., Marel ...

Info on Drug Compounding Facilities Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information contained in guidance on fees for human drug compounding...

Jadelle Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Population Council/Scherings Jadelle (levonorgestrel) implant was not withdrawn for r...