RESEARCH & DEVELOPMENT
Jazz Pharmaceuticals has an unwavering commitment to improving care for patients with serious medical conditions through innovative treatments. Our development pipeline projects currently include clinical development of new product candidates, line extensions for existing products and the generation of additional clinical data for existing products.
CLINICAL DEVELOPMENT PIPELINE
1 To be evaluated in children and adolescents aged 7-17 who have narcolepsy with cataplexy.
2 sBLA submitted in February 2014. FDA filed April 2014, PDUFA date of December 28, 2014.
3 Determining U.S. regulatory pathway.
4 Formerly known as Asparec. JZP-416 is pegcrisantaspase, the PEGylated Erwinia chrysanthemi L-asparaginase.
EDS = Excessive Daytime Sleepiness, OSA = Obstructive Sleep Apnea, ALL = Acute Lymphoblastic Leukemia,
IV = Intravenous, VOD = Hepatic Veno-Occlusive Disease, aGvHD = Acute Graft vs. Host Disease, YA = Young Adults,
sBLA = supplemental Biologics License Application, FDA = U.S. Food and Drug Administration,
PDUFA = Prescription Drug User Fee Act