CHADDS FORD, Pa., Sept. 22 /PRNewswire-FirstCall/ — Endo
Pharmaceuticals (Nasdaq:
ENDP) announced that it recently received notification from the
U.S. Food and Drug Administration (FDA) that Endo’s new drug
application (NDA) for its new oral formulation of long-acting
oxymorphone, which is designed to be crush resistant, has been
granted priority review status. The FDA has set the action
date under the Prescription Drug User Fee Act (PDUFA) for Jan. 7,
2011.
This new oxymorphone formulation is a semi-synthetic opioid
analgesic intended for the treatment of moderate to severe chronic
pain in patients requiring continuous, around-the-clock opioid
treatment for an extended period of time. It is a tablet
formulation designed to resist crushing, breaking, powdering or
pulverizing.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company, focused on high-value branded products and
specialty generics. Endo is redefining its position in the
healthcare marketplace by anticipating and embracing the evolution
of health decisions based on the need for high-quality and
cost-effective care. We aim to be the premier partner to healthcare
professionals and payment providers, delivering an innovative suite
of complementary diagnostics, drugs, devices and clinical data to
meet the needs of patients in areas such as pain, urology, oncology
and endocrinology. For more information about Endo Pharmaceuticals,
and its wholly owned subsidiary HealthTronics Inc., please visit www.endo.com.
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