KV Pharmaceutical drug delivery, generics news
KV reached a settlement with the Department of Justice and will pay $17 million over five years to resolve alleged False Claims Act violations by its former Ethex Corp. subsidiary. Specifically, DoJ alleged that Ethex failed to advise the Centers for Medicare and Medicaid Services (CMS) that two generic products - nitroglycerin and hyoscyamine sulfate extended release capsules - did not qualify for coverage under federal health care programs. KV said the settlement has "nominal" near-term capital requirements. Nitroglycerin is used to treat angina (chest pain) in patients with coronary artery disease (CAD), while hyoscyamine sulfate is used as adjunctive therapy for gastrointestinal disorders and peptic ulcers.
KV, which did not admit wrongdoing as part of the settlement, said that the government did not require a corporate integrity agreement after finding KV's current operations and compliance function "sufficiently robust." ...