Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Impax Laboratories has reported that its abbreviated new drug application for oxymorphone hydrochloride extended-release tablets CII, a generic version of Opana ER, has been accepted for filing by the FDA as of November 23, 2007.
Subscribe to our email newsletter
Despite the acceptance, the company continues to believe that its ANDA as originally filed met all the requirements for acceptance and thus will continue to pursue its administrative remedies with the FDA to reinstate its original filing date of June 29, 2007.
Larry Hsu, president and CEO of Impax, said: “We also intend to continue to vigorously defend the ongoing patent litigation as previously announced with Endo and Penwest and look forward to prevailing and bringing this important generic product to market.”