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FDA Seeks S&E Data on Ecamsule OTC Use

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Federal Register Notice: FDA requests safety and effectiveness data on the over-the-counter use of Ecamsule (terephthalylidene dic...

FDA OKs Talecris Biotherapeutics Orphan Drug

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FDA approves Talecris Biotherapeutics Gamunex, an immune globulin product indicated for treating chronic inflammatory demyelinatin...

FDA Approves Fougera ANDA for Generic Clotrimazole

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FDA approves a Fougera ANDA for a generic copy of Taros referenced listed product clotrimazole.

FDA Staffing Up 1,300

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FDA says it has hired more than 1,300 new staffers, with half of them going to CDER.

New Chantix Ad is 50% Risk Info

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Forbes magazine says a new 90-second TV spot for Pfizers anti-smoking drug Chantix includes 41 seconds of risk information.

Drug Label Preemption Likely to be Upheld: Attorney

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Attorney Robert Bourque predicts the U.S. Supreme Court will support FDA preemption of state failure-to-warn requirements in drug ...

FDA OKs Suns Generic Fosamax

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FDA approves a Sun Pharmaceutical Industries ANDA for a generic copy of Mercks Fosamax.

Novacea Scraps Prostate Drug Development

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Novacea says it has discontinued the development of its androgen-independent prostate cancer drug Asentar after a Phase 3 trial (A...

Gardasil Wins Vulvar/Vaginal Cancer Indications

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FDA approves two additional indications for Mercks Gardasil vaccine prevention of vaginal and vulvar cancer caused by human papil...

Plaisier Named New FDA Central Region Director

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FDA chooses associate commissioner for international programs Melinda Plaisier as its new Central Regional director, based in Chic...