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Grassley Questions Unapproved Drug Oversight

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Sen. Chuck Grassley asks FDA commissioner von Eschenbach for detailed information on the agencys efforts against manufacturers of ...

FDA Approves Robotic Hand Piece

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FDA approves Cardiogenesis PEARL robotic delivery system.

FDA Approves Generic Rimadyl

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FDA approves GeoPharmas generic form of Pfizers canine drug Rimadyl in three strengths.

One Dose Dropped in ANDES Trial

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AtheroGenics drops the 300 mg dose from its AGI-1067 ANDES clinical trial due to adverse effects on the liver seen in an earlier t...

FDA OKs New Formulation of Abbotts HIV Drug

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FDA approves a lower-strength formulation of Abbotts HIV protease inhibitor.

FDA OKs GeoPharmas Generic Rimadyl

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FDA approves GeoPharmas application for a generic copy of Pfizers Rimadyl (carprofen).

FDAs Office of Internal Affairs Removed from Investigations

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HHS Office of Inspector General abolishes a controversial memorandum of understanding that allowed FDAs Office of Internal Affairs...

FDA Tentatively OKs Caracos Generic Lamictal

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FDA tentatively approves a Caraco Pharmaceutical Laboratories ANDA for a generic copy of GlaxoSmithKlines Lamictal (lamotrigine) t...

Health Canada Severely Restricts Avandia Use

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Health Canada restricts most monotherapy and combination uses of GlaxoSmithKlines Avandia.

Cephalon Asks New Fentora Indication

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Cephalon submits an sNDA to FDA for a Fentora indication for managing breakthrough pain in opioid tolerant patients.