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FDA Withdraws Approval of Oxytetracycline ANADA

[ Price : $8.95]

Federal Register Notice: FDA withdraws approval of a Vetoquinol ANADA for oxytetracycline hydrochloride soluble powder.

Acura Pharma Petitions FDA on Purdue Pain Drug NDA

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Acura Pharmaceuticals petitions FDA asking it to rescind acceptance of a Purdue Pharma 505(b)(2) NDA that Acura believes was recen...

Genentech NDA Filed for Melanoma Therapy

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Genentech files an NDA for cobimetinib for treating, in combination with Zelboraf (vemurafenib), patients with BRAF V600 mutation-...

EOS Imaging Hip Arthroplasty Planning Software Approved

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FDA approves an EOS imaging PMA for its hipEOS, a 3D hip arthroplasty planning software based on EOS stereo-radiographic 2D/3D ima...

Acorda Seeks Tighter Bioequivalence for Generic Ampyra

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Acorda Therapeutics petitions FDA seeking rigorous bioequivalence requirements for proposed generic copies of its multiple scleros...

Baxter Recalls 2 Sodium Chloride Injection Lots

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Baxter International recalls two lots of 0.9% sodium chloride injection USP in 100 mL Mini-Bag Plus Container after two complaints...

FDA Clears diaDexus Heart Disease Test

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FDA clears a diaDexus 510(k) for a new screening test that predicts a patients risk of future coronary heart disease events.

Senators Introduce Dormant Therapies Act

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Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) have introduced the Dormant Therapies Act, a bill that will establish a new ...

Court Orders Actavis to Continue Distributing Namenda

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New York Attorney General Eric T. Schneiderman wins a preliminary injunction against Actavis that requires the company to continue...

FDA Approves Sanofi Pasteurs Fluzone Quadrivalent

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FDA approves a Sanofi Pasteur supplemental BLA for Fluzone Intradermal Quadrivalent vaccine.