Indevus Submits Nebido For Hypogonadism
This article was originally published in The Pink Sheet Daily
The long-acting testosterone could offer once every 12 week dosing compared to current treatment every two to three weeks.
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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.
FDA says reports of oil embolism and anaphylactic reations with other testosterone injectables also will be part of the discussion during an April 18 meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees to review Aveed (testosterone undecanoate).
New study is likely needed for Nebido approval, firm says.