Balanced Health Products expands its voluntary recall of StarCaps Diet Systemto include additional lots - numbers 12/2009-82866 and 12/2010-8301 - because the capsules in the 30-count bottles contain the undeclared ingredient bumetanide, a diuretic that can cause serious fluid and electrolyte loss. The firm says in a Dec. 8 release it believes an additional lot of raw material was contaminated with bumetanide in Lima, Peru. The company suspended StarCaps shipments after National Football League players alleged the product contained bumetanide, which can mask steroid use (1"The Tan Sheet" Nov. 3, 2008, In Brief)
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
