Irvine-based Allergan Inc. was warned about claims in a print advertisement for an acne drug, regulators said Friday.
The Food and Drug Administration said in a letter to Allergan that a medical journal ad for its Aczone “grossly overstates” the drug’s effectiveness, left out “important risk information” and suggested that the drug is safer than has been demonstrated.
Allergan spokeswoman Caroline Van Hove said in a Reuters report that the ad that regulators are concerned about ran during March, April and May and is no longer used.
A new Aczone ad that addresses the FDA’s concerns started running in May, Van Hove said.
The FDA’s letter said Allergan has until Aug. 28 to address the concerns raised in it.
