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CBER PMAs Listed

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Federal Register Notice: FDA publishes a list of approved CBER PMAs and announces the availability of their safety and effectivene...

FDA Approves OTC Zyrtec-D

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FDA approves the over-the-counter use of Pfizers allergy drug Zyrtec-D for adults and children 12 years of age and older.

Amgen Site with Off-label Claims Killed after News Exposure

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Hours after a Washington newsletter reports that Amgen Inc. funded a Web site on which patients made off-label claims for its drug...

Cephalon Settles Off-Label Actiq Claims

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Cephalon says it will pay $425 million and agree to one misdemeanor violation to resolve a federal probe of its Actiq marketing pr...

New Sprycel Labeling Approved

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FDA approves a lower recommended starting dose for Bristol-Myers Squibbs Sprycel for patients with chronic myeloid leukemia who ar...

FDA Reports Shortage of Merck Infant Vaccine

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FDA says that Merck is experiencing product shortages involving PedvaxHIB (Haemophilus B conjugate vaccine) due to manufacturing i...

FDA Approves New Crestor Indication

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FDA approves a new indication for AstraZenecas Crestor as a diet adjunct to slow atherosclerosis in patients with high cholesterol...