CombinatoRx Inc., of Cambridge, Mass., said the FDA has extended the PDUFA date for review of the Exalgo (hydromorphone HCl) extended-release tablets from Feb. 22 to March 1 due to federal government closings...Javelin Pharmaceuticals Inc., of Cambridge, Mass., said its new drug application to the FDA for its investigational product candidate Dyloject (diclofenac sodium) Injection has received an PDUFA date of Oct. 3
Alexza Pharmaceuticals Inc., of Mountain View, Calif., said the FDA accepted and filed its new drug application for AZ-004 (Staccato loxapine) in the treatment of agitation associated with schizophrenia or bipolar disorder, setting a PDUFA date of Oct. 11
Genzyme Corp., of Cambridge, Mass., has received a June 17 PDUFA date from the FDA for its biologics license application for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4,000 L scale
XenoPort Inc., of Santa Clara, Calif., disclosed during a presentation at the J.P. Morgan Healthcare Conference in San Francisco that no advisory panel has been called to review Solzira (gabapentin enacarbil) in restless legs syndrome prior to the Feb. 9 PDUFA date
Cadence Pharmaceuticals Inc., of San Diego, said the FDA extended the PDUFA date for priority review of Acetavance (intravenous acetaminophen) in pain and fever by three months, to Feb. 12, 2010
Labopharm Inc., of Laval, Quebec, said the FDA accepted its response regarding the agency's complete response letter for antidepressant drug trazodone as complete and designated it as a Class 2 resubmission, assigning a new PDUFA date of Feb. 11, 2010
Romidepsin, a histone deacetylase inhibitor, has orphan drug designation for non-Hodgkin's T-cell lymphomas, including CTCL, and has a PDUFA date of Nov. 12
United Therapeutics Corp., of Silver Spring, Md., said the FDA extended the PDUFA date for its pulmonary arterial hypertension drug Tyvaso (inhaled treprostinil) to July 30
The PDUFA date is set for Oct. 30