A decade after its first approval, FDA expands weight loss pill's label for use in adolescents
The FDA late Monday signed off on a supplemental indication for bankrupt Vivus’ Qsymia (phentermine and topiramate) for chronic weight management in obese adolescents aged 12 years and older, defined as those with a body mass index in the 95th percentile or greater.
First approved in 2012 for adults, Vivus struggled to sell Qsymia, ending up with less than $9 million in Q1 2020 sales, filing for bankruptcy later that same year, and then emerging from Chapter 11 as a wholly-owned subsidiary of Icahn Enterprises LP.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.