Propoxyphene Marketing Halted By FDAAA-Required QT Safety Study
This article was originally published in The Pink Sheet Daily
The opioid, marketed under the Darvon and Darvocet brands and in generic form, has the ignominious distinction of being the first drug pulled from the market based on results of a post-marketing safety study required under the 2007 law.
You may also be interested in...
Supreme Court asks the Solicitor General to weigh in on whether a state tort claim that Teva did not immediately update its generic Fosamax labeling is preempted by federal law; thousands of such suits have arisen in wake of high court’s Mensing decision.
FDA is trying multiple channels in social media to communicate drug safety information, but its two-way communication capacity is lower than many would like.
Bayer’s birth control pills Yasmin and Yaz face the most pharmaceutical product liability actions in federal court followed by Pfizer’s Prempro and GlaxoSmithKline’s Avandia. While GSK has settled the bulk of cases before a single trial, Merck and Novartis are winning Fosamax and Aredia jury verdicts.