Events Details
Kempharm's investigational drug receives "fast track" designation
Wednesday, May 11, 2016
Kempharm receives "fast track" designation for KP511, an investigational prodrug of hydromorphone.
Plans to seek approval of KP511/er under section 505(b)(2) of federal food, drug and cosmetic act.
Anticipated new drug application (NDA) submission as early as 2018.
Source : reuters.com
