Bayer discussing combo products
This article was originally published in The Tan Sheet
Executive Summary
Bayer HealthCare has responded to inquiries from FDA and the House Energy and Commerce Committee regarding the firm's OTC combination products, Anne Coiley, director of Bayer's global cardio communications in its consumer care division, says Nov. 18. FDA "has been in discussions with Bayer" and the "matter remains an open investigation," an FDA spokesperson confirms Nov. 19. Bayer received a letter from the House committee in October, followed by FDA warning letters on its products Bayer Aspirin With Heart Advantage,which adds phytosterols to aspirin, and Bayer Women's Low Dose Aspirin + Calcium. FDA's Oct. 27 warning letter notes the combo productsare technically unapproved new drugs (1"The Tan Sheet" Nov. 3, 2008, p. 9)
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Bayer HealthCare has responded to inquiries from FDA and the House Energy and Commerce Committee regarding the firm's OTC combination products, Anne Coiley, director of Bayer's global cardio communications in its consumer care division, says Nov. 18. FDA "has been in discussions with Bayer" and the "matter remains an open investigation," an FDA spokesperson confirms Nov. 19. Bayer received a letter from the House committee in October, followed by FDA warning letters on its products Bayer Aspirin With Heart Advantage ,which adds phytosterols to aspirin, and Bayer Women's Low Dose Aspirin + Calcium. FDA's Oct. 27 warning letter notes the combo productsare technically unapproved new drugs (1 (Also see "Bayer Warning Letters Reinforce FDA Ban On Supplement/Drug Combinations" - Pink Sheet, 3 Nov, 2008.), p. 9). |