Endo Gets Surprise Aveed Approval, But REMS Could Be A Roadblock
This article was originally published in The Pink Sheet Daily
After seven years of rejection, Endo finally gets FDA’s go-ahead on its long-acting testosterone treatment, but a strict REMS program and plenty of market competitors will make the drug’s launch difficult.
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Two advisory committees will discuss appropriate population for testosterone treatment and potential for adverse cardiovascular outcomes; product liability suits have been consolidated in Illinois federal court.
The specialty pharma’s CFO highlighted Endo’s recent restructuring and talked about its plans for M&A going forward at a recent health care conference.