Endo Branches Out With $370M Indevus Acquisition
This article was originally published in The Pink Sheet Daily
Re-submission of Nebido NDA in the wings, sales force will target general practitioners with urology, endocrinology drugs to general practitioners.
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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’s Reproductive Health Drugs and Risk Management advisory committees split on whether the safety of Endo’s injectable testosterone Aveed is safe for the proposed indication, with many on both sides seeing value in the drug for patients who “have to take testosterone.”
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).