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Indivior Knew Suboxone Film Did Not Have Greater Child Safety Than Tablet, Grand Jury Claims

 
• By Brenda Sandburg

Indictment alleges Indivior falsely cited concerns about pediatric exposure to tablets in discontinuing the formulation; FDA official says company tried to mislead agency and bar competition for Suboxone.

Indivior

The US FDA's assessment of the pediatric safety of Suboxone Film was cited in a federal grand jury indictment of Indivior PLC alleging the company fraudulently marketed the sublingual formulation of buprenorphine/naloxone as safer, less divertible and less abusable than other opioid addiction treatments. It also alleges that the company falsely cited concerns about pediatric exposure to the tablet as the reason for discontinuing the formulation and replacing it with the patent protected film product.

The charges are similar to fraudulent marketing claims that have been made against opioid makers

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