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FDA Delays Wholesale Blood Derivatives Rule

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Federal Register Final rule: FDA delays until 12/1/08 a final rule that would prohibit wholesale distribution of blood derivatives...

FDA Urges Drug Maker/Distributor Written Agreements

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FDA urges drug manufacturers to enter into written agreements with drug distributors with whom they have ongoing business relation...

FDA Moves to Improve Drug Safety

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FDA deputy commissioner for medical and scientific affairs Scott Gottlieb outlines new drug safety improvements at the agency that...

FDA Warns About Tamiflu-associated Abnormal Behavior

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FDA recommends a new precaution to be added to Roches influenza drug Tamiflu about abnormal behavior events seen in pediatric pati...

FDA Tentative OK for Generic Zyprexa

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FDA tentatively approves a Barr Pharmaceuticals ANDA for a generic version of Eli Lillys Zyprexa.

FDA Approves Restless Leg Syndrome Drug

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FDA approves a new indication for Boehringer Ingelheims Mirapex for treating restless leg syndrome.

Merck Sends MEDAL Results to FDA

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Merck says it has responded to FDAs approvable letter for Arcoxia.

Schwarz Pharma Wants Stay on Paddock ANDA

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Schwarz asks FDA not to approve a Paddock ANDA for moexipril HCL.

Dental Products Panel OKs New Infuse Indication

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FDAs Dental Products Advisory Panel recommends approval of a new indication for Medtronics Infuse Bone Graft for oral and maxillof...

FDA OKs Mylans Generic Ditropan

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FDA approves a Mylan Laboratories ANDA for a generic copy of Alzas Ditropan XL.