FDA denies Endo petition

FDA denied a 2012 Citizen's Petition from Endo Health Solutions Inc. (NASDAQ:ENDP) asking the agency to determine that the original formulation of the company's pain drug Opana ER oxymorphone had been withdrawn due to reasons of safety. As a result, the original NDA will remain a reference listed drug and two marketed, generic versions of oxymorphone will be allowed to remain on the market. FDA also issued a complete response letter to an sNDA from Endo seeking to add abuse-deterrent language to the label of its new, crush-resistant formulation of Opana ER. The agency said it disagreed with Endo's conclusions about the "alleged safety advantages" of the crush-resistant formulation of Opana ER, noting that the drug's extended release features "can be compromised, causing the product to 'dose dump' when subjected to other forms of manipulation such as cutting, grinding, or chewing, followed by swallowing." Endo was off $1.95 to $34.97 on Friday.

Last month, FDA said it will not accept or approve ANDAs for generic versions of OxyContin oxycodone from Purdue Pharma L.P. (Stamford, Conn.) that lack abuse-deterrent properties. The agency approved abuse-deterrent labeling for a reformulated version of OxyContin and determined that the NDA for the original formulation was withdrawn for reasons of safety and effectiveness (see BioCentury Extra, April 16). ...