Akorn receives FDA approval for topical gel

LAKE FOREST - Specialty pharmaceutical company Akorn Inc. received a generic drug approval from the U.S. Food and Drug Administration for the sale of diclofenac sodium topical gel, 1 percent.

Diclofenac sodium topical gel is used for the relief of the pain of osteoarthritis of joints, such as the knees and those of the hands. The product is manufactured at Akorn's Amityville, New York facility. It has not been evaluated for use on the spine, hip, or shoulder.

Data company IQVIA estimates the U.S. market for the drug was approximately $357 million for the twelve months ended September 2018, with three current competitors. Akorn officials said the IQVIA market size is not a forecast of future sales.