Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the company’s hydrocodone bitartrate extended-release (ER) tablets formulated with Teva’s proprietary abuse deterrence technology (CEP-33237). CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release 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.

"Teva is committed to developing innovative approaches to helping advance responsible pain management and is pleased the FDA is moving forward in its consideration of CEP-33237,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. "With positive results from Human Abuse Liability studies in the two most common routes of hydrocodone abuse, CEP-33237 with potential abuse deterrence properties, represents a positive step towards responsible pain management.”

For more details, go to: http://www.tevapharm.com/Media/News/Pages/2015/2019875.aspx