All Posts Tagged With: "bayer"
FDA sends Bayer Warning Letters for Marketing Unapproved Drugs
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved [...]
Popularity: 19% [?]
28Oct2008 | PharmaWatchDog | 0 comments | Continued
Leukine (sargramostim)
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally [...]
Popularity: 48% [?]
27Feb2008 | PharmaWatchDog | 0 comments | Continued
