FDA Cites Abbott’s Humira Psoriasis Ad: Patient Does Not Exhibit Severe Disease
This article was originally published in The Pink Sheet Daily
Executive Summary
Warning letter for Humira ad reprises agency interest in clear identification of appropriate patients.
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End Of The Year Approvals And Actions, In Brief
Ferring plans prostate cancer drug launch: After securing FDA approval of degarelix for advanced prostate cancer, the Swiss pharma is planning a launch in the first quarter after finalizing the trade name with FDA. Degarelix is a gonadotropin releasing hormone receptor antagonist that suppresses testosterone, and could have an advantage over existing hormonal treatments like Abbott's Lupron Depot because it hasn't shown the initial surge in testosterone production that has been seen with some other agents, according to FDA. Testosterone plays an important role in the growth of prostate cancer, so suppressing testosterone can slow the growth and progression of prostate tumors. Degarelix was compared to leuprolide in the Phase III study supporting approval. For the U.S. launch, Ferring plans to expand its existing urology sales force from 85 reps to 115
End Of The Year Approvals And Actions, In Brief
Ferring plans prostate cancer drug launch: After securing FDA approval of degarelix for advanced prostate cancer, the Swiss pharma is planning a launch in the first quarter after finalizing the trade name with FDA. Degarelix is a gonadotropin releasing hormone receptor antagonist that suppresses testosterone, and could have an advantage over existing hormonal treatments like Abbott's Lupron Depot because it hasn't shown the initial surge in testosterone production that has been seen with some other agents, according to FDA. Testosterone plays an important role in the growth of prostate cancer, so suppressing testosterone can slow the growth and progression of prostate tumors. Degarelix was compared to leuprolide in the Phase III study supporting approval. For the U.S. launch, Ferring plans to expand its existing urology sales force from 85 reps to 115
FDA Mandates New Boxed Warning For TNF Inhibitors
Four TNF-alpha blocker marketers asked to add Medication Guides and strengthen education programs to increase awareness of risk of fungal infections.