Teva Pharmaceutical Industries Limited Announces Initiation Of New Drug Application And Positive Results From Second Human Abuse Liability Study For CEP-33237 (Hydrocodone Bitartrate) Extended-Release Tablets

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced the initiation of a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties (CEP-33237) as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release (ER) hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Help employers find you! Check out all the jobs and post your resume.
MORE ON THIS TOPIC