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Antidepressant Suicide Warnings in Label Changes

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Among many July labeling changes, FDA approves boxed warnings for nine antidepressants cautioning against increased risk of suicid...

Oschner Fertility Center Cited for HCT/P Violations

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FDAs New Orleans District Office warns The Fertility Center at Ochsner over deviations from HCT/P regulations.

Aventis Pays $190 Million in Anzemet Pricing Case

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Sanofi-Aventis settles a whistleblower suit over Anzemet pricing and marketing for more than $190 million.

Drug Companies, White House Lose on Patent Bill

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The House passes patent reform legislation opposed by drug companies and the White House.

Reported Deaths from Drugs Jump Over 270%: Study

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A new study in the Archives of Internal Medicine finds that reported deaths associated with drug adverse events more than doubled ...

Frova Action Date Delayed

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FDA says it will issue an action letter 9/30 on Endo and Verrnalis sNDA for an expanded indication for Frova for short-term preven...

FDA Trasylol Safety Analysis Finds Renal Failure Risk

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An FDA safety evaluation of a Trasylol observational study that was mistakenly not provided last year finds the drug is associated...

Import Safety Framework Relies on Increased Cooperation

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A new HHS report on import safety says FDA and other agencies will need to increase their cooperation with foreign governments, fo...

MedWatch Warning on Pfizers Viracept

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Pfizer warns healthcare professionals about increased levels of ethyl methanesulfonate present in its HIV therapy Viracept, which ...

FDA Gives Orphan Status to Metabasis Cancer Drug

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FDA gives orphan drug status to Metabasis liver cancer drug candidate MBO7133.