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Allergan in $600 million Botox settlement
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02-Sep-2010
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Allergan has agreed to pay $375 million to settle criminal charges and $225 million to resolve civil claims as part of a settlement with the US Department of Justice over the company’s US sales and marketing practices related to Botox (onabotulinumtoxinA), which the government maintains the firm was promoting for a number of unapproved uses.
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Novartis wins FDA nod for blood pressure pill
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27-Aug-2010
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Novartis has won US Food and Drug Administration approval for a high blood pressure therapy called Tekamlo, which is a single-pill combination of the company’s renin inhibitor Tekturna (aliskiren) and the calcium channel blocker amlodipine, which is the active ingredient in Pfizer’s top-selling high blood pressure medication Norvasc
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J&J’s DePuy recalls devices
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27-Aug-2010
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Johnson & Johnson’s DePuy Orthopaedics unit is recalling two kinds of hip implants that appear to be linked to the need for a higher number of second procedures known as revision surgeries
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US News in Brief, August 26, 2010
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26-Aug-2010
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Cephalon CEO on leave Stem cell ruling will be appealed P&G to co-promote sleep drug EpiCept Ceplene NDA rejected Pfizer lung cancer study disappoints FDA advisors back expanded Cymbalta use Jazz drug nixed by FDA advisors
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Bill would increase FDA recall powers
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06-Aug-2010
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New legislation has been introduced in the Senate that would give the US Food and Drug Administration the authority to force companies to recall drugs in cases in which the products have been found to be contaminated or unsafe
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US News in Brief, August 6, 2010
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06-Aug-2010
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Study suggests bias in industry research FDA lifts hold on stem-cell trial New flu shots approved GSK forms two new drug partnerships New recommendations on FDA device reviews
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US News in Brief, July 30, 2010
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30-Jul-2010
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FDA clears Daiichi hypertension drug
Merck Serono MS pill wins priority review
Astellas and Regeneron extend deal
Counterfeit medicines summit
FDA approves drug for drooling
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First generic Lovenox approved
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29-Jul-2010
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In a controversial move, the US Food and Drug Administration has approved for marketing the first generic version of sanofi-aventis’ blockbuster blood-thinner Lovenox (enoxaparin sodium injection), which is indicated for a number of uses, including prevention of deep vein thrombosis
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