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Endo Aveed’s Safety Problems Weigh On Cmte., But Hope For Narrower Population Tips Scale For Some

 
• By Sarah Karlin-Smith

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.”

A narrower indication for a more targeted patient population may offer a path forward for Endo Pharmaceuticals Solutions Inc.’s long-acting injectable testosterone gel Aveed (testosterone undecanoate), a joint panel of FDA’s Reproductive Health Drugs and Risk Management advisory committees indicated April 18.

The committee members split 9-9 on whether given severe post-injection reactions reported in clinical studies and in postmarketing abroad Aveed is safe for the proposed indication of replacement therapy in adult males for conditions associated with a

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