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Synthon Pharmaceuticals Generic Xyzal Approved

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FDA approves a Synthon Pharmaceuticals ANDA for a generic version of UCB's Xyzal oral solution, indicated for treating indoor and ...

FDA Loses Cigarette Warning First Amendment Challenge

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FDA loses on First Amendment grounds its bid to require cigarette makers to place graphic warnings on their products while a broad...

Hamburg Taps Law Partner as Staff Chief

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FDA commissioner Margaret Hamburg chooses former Zuckerman Spaeder partner Lisa Barclay as her new chief of staff.

Report on Medical Product Shortages

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Federal Register Notice: FDA releases a report on medical product shortages and requests comments.

Gilead Seeks New Five-year Data on Viread Labeling

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Gilead Sciences asks FDA to add new Viread (tenofovir disoproxil fumarate) labeling based on five-year data from two open-label Ph...

FDA Reminds Avandia Patients of Access Deadline

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FDA reminds healthcare providers and patients of the 11/17 deadline to enroll in the Avandia-Rosiglitazone Medicines Access Progra...

Appeals Court Rules Against Companies on Grandfathered Drug

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A federal appeals court rules against Cody Laboratories and Lannett Co. in their bid to challenge FDAs Unapproved Drugs Initiative...

FDA Approves Janssen's Xarelto for Stroke Prevention

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FDA approves a Janssen Pharmaceuticals NDA for Xarelto (rivaroxaban), indicated for preventing stroke and systemic embolism in pat...

Will Supreme Court Settle 'Off-label Promo Conundrum?

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FDA watchers hope the U.S. Supreme Court will soon put to rest First Amendment arguments surrounding the agencys restrictions on o...

FDA Allows Octagam Back on the Market

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FDA approves the market return of Octapharmas Octagam [immune globulin intravenous (human) 5% liquid preparation] for use in treat...