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
