Kythera Biopharmaceuticals Inc. said in a news release that injections of the drug have been shown in clinical studies to be both safe and effective in reducing fat under the chin.
It will sell the drug under the brand name Kybella. The company plans to launch the drug this summer through physicians who complete a training program.
"For the first time, people have access to an FDA-approved, non-surgical treatment" for double chins, said Keith Leonard, chief executive of Kythera.
In an interview with The Times in 2013, Leonard said he thought the drug could eventually generate more than $500 million in annual sales.
"We really think we're going to be the next big thing in aesthetics," he said.
Kythera's stock fell $2.05, or 4.3%, to $45.59. The FDA approval had been widely expected.
Kybella will be administered during in-office doctor visits that typically last 15 to 20 minutes. Many patients saw visible results after two to four visits, the company said, but up to six treatments may be administered.
In addition to physical benefits, patients in the clinical trials reported being less self-conscious, Kythera said.
Fat under the chin can affect men and women, regardless of age or weight.
"I see many patients who have undesirable fullness under the chin, even though they may have an otherwise balanced and harmonious facial appearance and be in great physical shape," said Dr. Derek H. Jones, a UCLA dermatology professor and lead investigator in clinical studies of the drug.
Fat below the chin "is often resistant to diet and exercise" and could be caused by aging or genetics, Jones said.
Dr. Michael Edwards, president of the American Society for Aesthetic Plastic Surgery, said he believes Kybella is a "true innovation in the aesthetic industry."
"We are excited about its potential," he said.