www.fdanews.com/articles/183612-uk-self-regulatory-association-blows-whistle-on-four-drugmakers
UK Self-Regulatory Association Blows Whistle on Four Drugmakers
September 20, 2017
A UK drug-industry trade association flagged Astellas, Norartis, Pfizer and Tor Generics for violating the group’s good-conduct guidelines.
The Prescription Medicines Code of Practice Authority, a self-regulatory arm of the Association of the British Pharmaceutical Industry, said:
- Astellas UK and Astellas Europe provided prescribing information for their medicines that was incomplete, omitting reports of adverse events;
- Pfizer and Novartis misleadingly promoted the Ultibro Breezhaler (indacaterol/glycopyrronium) in ways that went beyond its licensed indication and produced sales material that was unclear; and
- Tor Generics advertised Tor-bac (saline solution for injection) in a magazine before the product was licensed.