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Glaxo Submits Breast Cancer NDA

[ Price : $8.95]

GlaxoSmithKline submits an NDA for Tykerb (lapatinib ditosylate) for use in combination therapy with Roches Xeloda (capecitabine) ...

AARP Ads Back Drug Imports

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AARP breaks an ad campaign in 14 states calling for voters to urge senators to co-sponsor drug import legislation.

FDA Approves Scherings Noxafil for Fungal Infections

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FDA approves Scherings Noxafil for preventing mold and yeast-like fungal infections in patients with compromised immunity systems....

Medtronics Prestige Cervical Disc Data Non-inferior: FDA

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CDRH reviewers say data from Medtronics PMA on its Prestige Cervical Disc showed non-inferior results compared to the control grou...

Less Than Half of Pediatric Studies are Published: FDA

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FDA writing in JAMA says less than half of the 253 pediatric studies submitted to FDA under the 1997 pediatric exclusivity provisi...

FDA CLIA Waiver on Lead Poisoning Test

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FDA grants a CLIA waiver request that broadens access to a portable lead poisoning test to nontraditional lab sites.

New Drug Labels Disappoint FDA

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CDER Office of Medical Policy deputy director Rachel Behrman says drug labels intended to conform to the agencys new rules are not...

Rx Marketing Felonies Lead U.S. FDA-law Prosecutions

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A Justice Department lawyer tells FDLI that since 1990, most prosecutions under the Food, Drug and Cosmetic Act have been brought ...

Appeals Court Backs Waxman-Hatch Settlements

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The U.S. Court of Appeals for the Second Circuit upholds the legality of a Nolvadex patent challenge agreement between Barr Pharma...

PhRMA Says Companies Implementing Ad Principles

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Drug companies report receiving complaints and praise for their DTC ads relating to PhRMAs guiding principles.