Firms Explore First-In-Class Switches With NSURE Still In Limbo
This article was originally published in The Tan Sheet
Executive Summary
Firms are moving forward with potential first-in-class switches for chronic conditions, says Concentrics Research CEO Julie Aker. Meanwhile, FDA’s NSURE initiative offers “a lot of opportunity,” but “is still very conceptual,” the agency says.
You may also be interested in...
In Brief: Furness in new CDER role; Oxytrol for Women at retail; advisories on drug-tainted sex enhancers; senators want energy drink restrictions
Furness takes on new CDER role; Merck’s Oxytrol OTC arrives at retail; FDA issues advisory on drug-tainted sex enhancers; senators want energy drink restrictions; more news In Brief.
FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney
Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.
Merck’s Oxytrol Could Be OTC Trailblazer For Chronic Conditions
Merck’s Oxytrol for Women has the opportunity to “create the market” for OTC overactive bladder drugs, as well as encourage other switches for chronic, progressive conditions, marketing consultant Joe McGovern says. The transdermal patch product is slated to launch in September.