Wednesday, September 25, 2013

Endo Pharmaceuticals Inc's NDA for testosterone undecanoate injection accepted for review by the US FDA





Sep 06, 2013 (Menafn - M2 EQUITYBITES via COMTEX) --Endo Pharmaceuticals Inc revealed on Thursday that the US Food and Drug Administration (FDA) has accepted for review the complete response submission for its new drug application (NDA) for its long-acting testosterone undecanoate injection, AVEED.

In conjunction with the FDA's acceptance, the company's NDA has been assigned a new Prescription Drug User Fee Act (PDUFA) action date of 28 February 2014.

The company added AVEED is being studied for men that are diagnosed with hypogonadism.
Endo Pharmaceuticals Inc is healthcare company and a subsidiary of Endo Health Solutions Inc (nasdaqgs:ENDP).

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