Daily Archives: April 5, 2016

Case 1 “New Class”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

The first is new class. The brand examples are from my experience with Cozaar & Hyzaar, these are A-II receptor blockers for hypertension. The other is Celebrex. It was the first COX-2 inhibitor for arthritis. The key claim in both of these was that they were first in a new class of treatments for their respective diseases. They were effective without causing a specific and well-understood side effect in the class. In the case of Cozaar and Hyzaar, there was a reduced incidence of ACE inhibitor cough. In the case of Celebrex, there was greatly reduced NSAID gastrointestinal problem. Cozaar […]