The US Food and Drug Administration gave remarkable consideration to GlaxoSmithKline plc’s citizen petition asking the agency to review information about use of the antiemetic Zofran (ondansetron) during pregnancy. But the agency ultimately denied the petition, saying the company was asking it to weigh in on a “hypothetical question.”
GSK filed the petition last year requesting that the agency consider four categories of information and either change or affirm...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?