On Thursday, 35 US states and the District of Colombia filed a lawsuit again the the opioid maker Indivior, alleging that the company tried to keep generic versions of a drug off the market.
Indivior makes Suboxone, a drug used to treat heroine addicts and addicts of other painkillers.
According to the lawsuit by the states, Indivior told the FDA that it planned to offer a new “sublingual film,” or dissolvable strip version of the drug, which had been licensed to Indivior by MonoSol.
Since the strip was not equivalent to the tablet version of the drug, it would prevent pharmacists from prescribing a cheaper generic alternative to patients.
The lawsuit claims that the company persuaded the FDA to approve the strip by raising concerns that the tablet posed high exposure risks to children. It later used those pediatric safety claims again to try to persuade the FDA not to approve generic tablets of Suboxone.
The complaint alleges that although the FDA rejected the company’s arguments, by the time the generics hit the marketplace, many patients had already switched over to using the dissolvable strip. There is currently no generic version of the dissolvable strip.
Full Content: CNBC
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