This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAdditional data from NIH's ALLHAT study is needed before any changes are made to labeling for Pfizer's antihypertensive doxazosin, FDA's Cardiovascular and Renal Drugs Advisory Committee recommends at its May 24 meeting. The group met to discuss whether labeling should reflect preliminary data from the study, which suggests Cardura patients were twice as likely as the control group to be hospitalized for congestive heart failure. The CHF risk was 8.1% for the doxazosin patients and 4.5% for the chlorthalidone patients. The doxazosin arm of the study was halted in January 2000 based on a low probability of demonstrating superior efficacy to chlorthalidone and a higher rate of CHF
You may also be interested in...
Hours before the US FDA confirmed the first drug shortage due to active pharmaceutical ingredient constraints because of the coronavirus situation in China, generics industry leader Mylan came under pressure about the potential impact on its business.
Government advisory committee gives initial nod to what will become Japan’s most expensive single drug, but reimbursement pricing could come in for close scrutiny.
Laparoscopic power morcellation to remove uterine fibroids should only be performed with the use of a compatible containment system, and only on women younger than 50, the US FDA said in a newly published safety communication and draft guidance document. See what the president of the gynecologic trade group AAGL, Jubilee Brown, said about it here.