Japan's health ministry said Thursday it has filed a criminal complaint against Novartis Pharma, alleging exaggerated advertising for the heart condition and blood-pressure lowering drug Diovan.
Novartis Pharma K.K., the local unit of Swiss pharmaceutical group Novartis AG, issued an apology on its website for "troubles and concerns" over the advertising. It said the company takes the issue very seriously and is cooperating with authorities.
The ads cited clinical studies conducted by two Japanese hospitals that included false data.
The Health, Labor and Welfare Ministry said in a notice it suspects Novartis continued using ads citing the studies after learning data in them had been manipulated. Novartis has denied it was aware of the problem, and says studies have confirmed the safety and effectiveness of the drug.
Diovan, also known as valsartan, is a blockbuster drug for Novartis that is sold around the world.
Separately, state and federal prosecutors in New York allege in a civil case against the U.S. arm of Novartis that it paid kickbacks to a specialty pharmacy in exchange for recommending refills of a blood transfusion drug it produces.