GSK Malarone Label Drops Renal Precautions
This article was originally published in The Pink Sheet Daily
Malaria treatment "may be used with caution" in patients with severe renal impairment when benefits outweigh risks. The new labeling also notes potential psychotic adverse reactions.
You may also be interested in...
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter
Amgen's failed Anemia of Cancer trial of Aranesp and Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial of Vectibix may illustrate the potential pitfalls facing sponsors that conduct "real world" trials of their products
A substantial portion of European patients purchasing Sanofi-Aventis' Acomplia pay entirely out-of-pocket for the obesity drug