Endo’s Testosterone REMS, Revised Dosing Don’t Solve FDA Concerns
This article was originally published in The Pink Sheet Daily
FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.
You may also be interested in...
Without predictive factors to determine who is likely to get a severe post-injection reaction, FDA advisory committees say Endo’s proposed REMS for its long-acting testosterone is unlikely to allay safety concerns.
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).