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FDAnews Drug Daily Bulletin

UK Self-Regulatory Association Blows Whistle on Four Drugmakers

Sept. 21, 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.

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