Third Time’s A Charm? Endo’s Injectable Testosterone Finally Ready For Advisory Cmte.

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).

FDA will take its concerns about post-marketing reports of oil embolism in the lungs and potential anaphylactic reactions associated with Endo Pharmaceuticals Solutions Inc.’s Aveed (testosterone undecanoate), which is administered as an intramuscular oil-based injection, to the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees April 18.

The two safety question marks have plagued the drug in its quest for FDA approval since Indevus Pharmaceuticals first filed...

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