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We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue shortly after the 1998 FDA Guidelines were published. The arguments Continue reading Is the AOM Indication Making a Come-Back?
Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004. Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing
Shortly after Domagk and Hörlein announced their discovery of the antibacterial properties of the dye sulfamidochrysoidine (Prontosil) in 1935, numerous chemical companies set out to modify the chemical structure. They soon recognized the sulfa component as the true antibacterial and produced an incredible number of derivatives (more than 5000 different compounds!!) by 1945.[1, Continue reading The Rapid Rise of Sulfonamide Diversity