KV Pharmaceutical has agreed to pay $17 million to resolve allegations that a subsidiary, Ethex Corporation, misrepresented the regulatory status of two of its drugs, Nitroglycerin Extended Release Capsules and Hyoscyamine Sulfate Extended Release Capsules.  According to the complaint, the FDA made determinations in the 1990s that the drugs were ineligible for coverage under federal healthcare programs.  Neither drug ever received full FDA approval and both of them have since been pulled off the market.

The whistleblower who brought the case to the government’s attention will receive over $1.5 million from the federal government’s share and a portion of the states’ share that has yet to be determined.  Since January 2009, the Justice Department has collected over $8.5 billion through False Claims Act cases.

Read the entire article, “St. Louis-Based KV Pharmaceutical to Pay $17 Million to Settle False Claims Allegations Received Reimbursement for Unapproved Drugs”