Endo Pharmaceuticals Receives FDA Priority Review for New Formulation of Long-Acting Oxymorphone Designed to be Crush Resistant; PDUFA Date Set for January 7
Published: Sep 22, 2010
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.
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.
SOURCE Endo Pharmaceuticals