Pharmaceutical company Akorn Operating Company LLC (Akorn) has agreed to pay $7.9 million to resolve allegations that it caused the submission of false claims to Medicare Part D, in violation of the False Claims Act, for three generic drugs that were no longer eligible for Medicare coverage.
FDA-approved “prescription only” (Rx-only) drugs may be dispensed only upon a prescription and are reimbursed by Medicare Part D, whereas “over the counter” (OTC) drugs may be purchased by retail customers without a prescription and are not reimbursed by Medicare Part D. Subject to FDA approval, companies may seek to fully convert a brand-name Rx-only drug to an OTC drug. After FDA’s approval of a drug’s full conversion to OTC status, the drug is no longer considered an Rx-only product and makers of generic equivalents are then required either to seek FDA approval for their own OTC switch or to seek withdrawal of their generic’s Rx-only approval and cease marketing it.
Akorn is a pharmaceutical manufacturer with a principal place of business in Illinois, which sold, among other products, the following generic drugs: (1) Diclofenac Sodium 1%, a generic nonsteroidal anti-inflammatory cream (Diclofenac), (2) Olopatadine Hydrocholoride 0.1% and 0.2%, a generic antihistamine eyedrop (Olopatadine), and (3) Azelastine Hydrochloride 0.15%, a generic antihistamine nasal spray (Azelastine) (collectively Akorn Generics) during the relevant time period. The FDA approved a full Rx-to-OTC conversion...
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