Indivior Submits Products For Approval Outside The US, Where Pressures Mount
Indivior is working on receiving ex-US approvals for its opioid abuse treatment products and building its cash reserves but faces future uncertainty over US generic competition and a US Department of Justice legal action.
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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.
Alvogen and Dr Reddy’s have launched generic versions of Indivior’s Suboxone in the US, after the Supreme Court denied the originator’s attempt to further frustrate generic launches. But these two versions will compete with an authorized generic launched by Indivior through Sandoz.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.