The US Department of Justice has announced that Akorn will pay $7.9 million to settle a case related to submission of false claims to Medicare Part D after the company continued to sell three products, including azelastine nasal spray, as prescription drugs after conversion to over-the-counter. The allegations were initially made in a suit brought by a whistleblower on behalf of the United States; that person will receive approximately $946,000.
Akorn’s generic azelastine nasal spray (0.15%) was approved by the FDA in August 2019. The company’s ANDA for 0.10% azelastine nasal spray, which was approved in May 2019, is still listed in the FDA approved drugs database and is not part of the case.
As part of the settlement, Akorn acknowledged that it continued to manufacture and sell the nasal spray and two other drugs under Rx-only labels instead of seeking approval for OTC sales when it was required to do so. The company also admitted that the reason it continued to sell the drugs as prescription-only was because it thought that selling them OTC would be less profitable. Medicare Part D covers prescription-only drugs but does not reimburse for over-the-counter drugs.
According to the Department of Justice, after the FDA approved an Rx-to-OTC conversion for Astepro azelastine nasal spray, 0.15%, which is the reference listed drug for Akorn’s ANDA, Akorn waited approximately 6 months until January 2022 before asking the agency to withdraw approval of its ANDA for azelastine nasal spray 0.15% instead of initiating the process of converting its nasal spray to OTC. The FDA withdrew the approval in February 2022.
Read the Justice Department press release.
