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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.

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...