LONDON — The United States on Wednesday approved the drug dosing for acne treatment of the skin, the first time such a treatment has been approved for the condition.
The approval is expected to ease concerns about side effects and bring back to the US a drug once seen as a niche drug for the elderly.
Dosage for the drug, diclofenac, will be based on the standard dose, which is about 400 to 1,000 milligrams a day.
The drug has been available in Europe since 2011.
Dosages for the drugs have been limited to about 100 milligrammes in some patients, said David A. Daley, chief medical officer of NewYork-Presbyterian/Columbia Hospital Center.
“Dosaging for these types of drugs is really a matter of trial and error,” Daley said.
For now, the drug can be taken orally, he said.
The U.S. Food and Drug Administration approved the drugs in December.
The approval came about four years after it was approved in Canada.
In the U.K., a group of academics has raised concerns that dicclofenaxone may not be a safe option for acne, the most common form of acne.
An FDA spokeswoman said dicluofenazone has not been tested on patients with acne or in children under the age of five, and she could not comment further.
Some experts say diclonazone is a more suitable treatment for acne because it has fewer side effects.
If approved, the treatment would be used in Europe, where diclorazone was first approved in 2014, but is now widely available.