DDMAC Warns Slate Pharma for Testosterone Drug Ads

The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has cited Slate Pharmaceuticals for marketing claims that promote unapproved uses of its testosterone drug Testopel, omit and minimize risk information, broaden its indication and overstate its efficacy. The materials include a sales aid, web pages and an online video, according to the March 24 letter. The company also failed to submit the web pages and video to the FDA for review.
Washington Drug Letter