Akorn Receives Product Approval

Akorn (Nasdaq:AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration for diclofenac sodium topical gel, 1%.  The product is manufactured at Akorn’s Amityville, New York manufacturing facility.

As quoted in the press release:

According to IQVIA, the U.S. market for diclofenac sodium topical gel, 1% was approximately $357 million for the twelve months ended September 2018, with three current competitors. The IQVIA market size is not a forecast of our future sales.

Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder.

Click here to read the full press release.