Tag Archives: FDA

Baxter Receives Third FDA Warning for Misleading Promotional Material

FDA issued a warning letter to Baxter International for making “misleading efficacy claims” about its lung drug Araplast NP, which is contraindicated in individuals with selective IgA deficiencies and prescribed to patients who are at increased risk of emphysema. FDA’s letter, dated Aug. 3, takes issue with claims in a brochure aimed at physicians that [...]
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Weight-Loss Drug Qnexa Loses in FDA Committee Ruling

Vivus’ Qnexa may help in weight loss, but it also now risks losing its place in the market following FDA’s Advisory Committee’s ruling July 15. The panel of medical experts did not question the effectiveness of the drug, but rather voiced its concerns over safety of the medication. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee [...]
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Avandia on Trial

The mid-July FDA advisory committee meeting to decide the fate of GlaxoSmithKline’s Avandia (rosiglitazone) is widely viewed as a test case of how the agency’s new leadership will address controversial drugs with serious risks but confusing data. A request that GSK yank its diabetes blockbuster—three years after first being associated with an increased risk of [...]
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Hamburg Delivers DIA Keynote

FDA Commissioner Margaret Hamburg delivered this year’s keynote speech in front of a packed room of pharma and bioscience personnel at the 46th annual meeting of the Drug Information Association, which opened Monday morning. Hamburg started her speech by explaining how her earliest goal as FDA chief was to build the field of regulatory [...]
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Johnson & Johnson Slammed Over Manufacturing Practices, Phantom Recall

In 1982, Johnson & Johnson garnered an enduring amount of goodwill when, seemingly without any thought of lost profit, it immediately yanked Tylenol from the shelves nationwide after learning someone was slipping cyanide into bottles in Chicago. The company’s sure and swift PR response became the model for crisis management for the corporate world. But in [...]
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