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FDA 'Smoke & Mirrors' Report Shows Record Approvals

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A new FDA report uses some smoke and mirrors to accentuate its approval record for last fiscal year.

CVM Corrects Erroneous Antimicrobials Sales Report

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CVM replaces an incomplete summary report on antimicrobials sold or distributed last year for use in food-producing animals.

Comments Sought on Device Mfr. Electronic Submissions

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Federal Register Notice: FDA seeks comments on the agency requirement that device establishments submit registration and listing i...

FDA Accepts Qnexa NDA for Obesity

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FDA accepts for review a Vivus NDA resubmission for Qnexa to treat obesity.

Abbott Sues Perrigo Over Androgel Patent Infringement

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Abbott sues Perrigo for Androgel patent infringement after Perrigo files an NDA for testosterone gel 1%.

Glaxo to Pay $3 Billion to Settle Marketing Probes

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GlaxoSmithKline expects to finalize a $3 billion settlement with the federal government in 2012 to resolve a number of outstanding...

Researcher Criticizes FDA Chantix Studies, Conclusions

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Researchers say that Pfizers Chantix has too many neuropsychiatric risks to be used as a first-line smoking cessation treatment.

TechneLite Panel Omits Risk Info

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CDERs Office of Prescription Drug Promotion says that a Lantheus TechneLite exhibit board omits important risk information and mak...

Enhanced Safety Surveillance for TNF Blockers

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FDA says enhanced tumor necrosis factor manufacturer surveillance of malignancies in children and young adults will help it better...

FDA OKs Luitpold Generic Elestat

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FDA approves a PharmaForce/Luitpold Pharmaceuticals ANDA for a generic version of Merck's Elestat.