FDA delays PDUFA goals
FDA will extend PDUFA goals due last week and this week for up to five business days as a result of federal government closures last week. For PDUFA dates of Feb. 22 and beyond, the agency will extend the reviews as needed. CombinatoRx Inc. (NASDAQ:CRXX) and commercialization partner Covidien plc (NYSE:COV) said FDA extended the PDUFA date for an NDA for Exalgo hydromorphone to manage moderate to severe pain in opioid-tolerant patients to March 1 from Feb. 22. CombinatoRx was up $0.05 to $1.34 on Tuesday.
Other applications affected by the closures include an NDA from XenoPort Inc. (NASDAQ:XNPT) for Horizant gabapentin enacarbil ( XP13512, GSK1838262) to treat restless legs syndrome (RLS), which had a Feb. 11 PDUFA date; and an NDA from Gilead Sciences Inc. (NASDAQ:GILD) for Cayston aztreonam lysine to improve respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa infections, which had a Feb. 13 PDUFA date. XenoPort and Gilead said they had not received a specific update from FDA on their respective applications. ...