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FDA Lifts Avandia Restrictions Based on New Data

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FDA lifts prescribing and dispensing restrictions on rosiglitazone-containing diabetes drugs based on new data that do not show an...

OPDP Cites Promo Letter for New Nausea Drug

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FDA cites Duchesnay for a violative letter that announced its NDA approval for Diclegis (doxylamine succinate and pyridoxine hydro...

FDA Nixes Exemption Request for Generic Drug User Fees

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FDA denies a citizen petition from generic drug newcomer Square Pharmaceuticals that sought an agency exception from generic drug ...

Supply Disruption on Meridian Medical Drugs

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FDA says there is a supply disruption involving Meridian Medical Technologies Atropen (atropine), DuoDote (atropine/pralidoxime ch...

FDA Approves Nexavar to Treat Type of Thyroid Cancer

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FDA approves a Bayer HealthCare Pharmaceuticals NDA to expand the use of Nexavar (sorafenib) to treat late-stage differentiated th...

FDA Approves First Adjuvanted H5N1 Vaccine

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FDA approves an ID Biomedical BLA for the first adjuvanted vaccine for preventing H5N1 influenza (avian or bird flu).

FDA Withdraws 3 NADAs

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Federal Register Notice: FDA withdraws approval of three Zoetis Inc. NADAs that are no longer marketed.

FDA Cites Amgen Over Aranesp Direct Mailer

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FDA cites an Amgen direct mailer piece for its anemia therapy Aranesp (darbepoetin alfa) because it omits important risk informati...

FDA Clears Kinetic Concepts Wound Therapy

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FDA clears a Kinetic Concepts 510(k) for its next generation V.A.C. Via Negative Pressure Wound Therapy System.

FDA Disbands Vet Medicine Advisory Committee

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FDA disbands its Veterinary Medicine Advisory Committee because it says panel advice has become obsolete.