NDA Granted Priority Review for Hydrocodone Bitartrate
Purdue Pharma announced that the FDA has granted Priority Review designation to hydrocodone bitartrate tablets (HYD), an investigational once-daily pain medication. The abuse-deterrent properties of hydrocodone bitartrate is designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration.
To investigate the abuse-deterrent properties of this investigational formulation, Purdue conducted a series of manipulation and extraction studies and clinical abuse liability studies.
Previously in April 2014, Purdue Pharma submitted a New Drug Application (NDA) for hydrocodone bitartrate tablet (HYD).
For more information call (888) 726-7535 or visit PurduePharma.com.