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Drug manufacturer Akorn Operating Company agreed to pay $7.9 million in a settlement with the Department of Justice (DOJ) for continuing to sell three drugs through Medicare when they were no longer covered under the program.
Akorn, of Illinois, received approval from the Food and Drug Administration (FDA) to make three generic drugs—Diclofenac, Olopatadine, and Azelastine—available to patients through Medicare, the federal health program for seniors, according to the settlement agreement announced Wednesday. The DOJ’s case grew from a June 2021 whistleblower lawsuit filed by Albermarle LLC in U.S. District Court for the District of Massachusetts under the qui tam provisions of the False Claims Act.
Generics are less-expensive prescription equivalents to brand-name prescription drugs. Drug companies may convert their brand-name prescription drugs to over-the-counter (OTC) drugs by filing conversion applications with the FDA. Any prescription generic equivalents must also switch to OTC status when the brand-name drug converts.
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