Federal officials did not approve Contrave, the weight loss drug developed by Orexigen Therapeutics, over concerns about the risks of heart problems.
The FDA said Orexigen must first conduct a long-term study to evaluate whether the obesity drug raises the risk of heart attacks.
An FDA panel had issued a positive recommendation for Contrave in December. If approved, Contrave would have been the first new prescription diet drug to be introduced to the US market in more than 10 years.
In the last year, the market for weight loss drugs has gone up and down, following Abbott Laboratories' decision to pull Meridia and the FDA's rejection of lorcaserin from Arena Pharmaceuticals and Qnexa from Vivus.
In December, The Los Angeles Times wrote:
As drug after drug falters or falls by the wayside, doctors who treat obese patients are growing increasingly frustrated. They say that the agency's standards for approving anti-obesity drugs are overly stringent and fail to recognize the health risks associated with carrying extra weight — at a time when almost 34% of U.S. adults are obese and almost 6% are morbidly obese, and when study after study has shown that the most that can be hoped for from diets and exercise, on average, is a 10% loss of body weight sustained for at least one year.
Orexigen entered into a deal with the Takeda Pharmaceutical Company in September to secure the North America marketing rights to Contrave for a $50 million upfront fee.