NuPathe submitted the application in October for Zelrix, a transdermal patch for treating migraine, and expects a PDUFA date of Aug. 29

The drug has a PDUFA date of April 29, 2011

Human Genome Sciences Inc., of Rockville, Md., and its partner GlaxoSmithKline plc, of London, reported that the FDA extended the PDUFA date for priority review of the biologics license application for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus from Dec. 9, 2010, to March 10, 2011

Taliglucerase alfa, branded Uplyso, is under review by the FDA, with a PDUFA date of Feb. 25, 2011

The FDA designated the resubmission as a Class 2 response and set a new PDUFA date of April 6, 2011. (See BioWorld Today, Feb. 19, 2010

That drug is under review, with a PDUFA date of Oct. 28, though an advisory panel recommended against approval earlier this year. (See BioWorld Today, July 19, 2010

11 PDUFA date to review the supplemental new drug application for H.P. Acthar Gel (repository corticotropin injection) for infantile spasms

The PDUFA date now is set in December

Human Genome Sciences Inc., of Rockville, Md., and partner GlaxoSmithKline plc, of London, said the FDA granted priority review designation to Benlysta (belimumab) in systemic lupus erythmatosus and assigned a Dec. 9 PDUFA date

The FDA previously set a PDUFA date of Jan. 31 , 201 1

The agency is expected to classify the complete response and provide the firms with an updated PDUFA date within the next two weeks

The PDUFA date is set for Aug. 3

The original panel meeting was set for February but had to be delayed due to administrative delays at the FDA, so the PDUFA date has been extended to July 27. (See BioWorld Today, June 2, 2009

The PDUFA date is July 24. (See BioWorld Today, Sept. 28, 2009

Dendreon Corp., of Seattle, apparently will not have to take its prostate cancer vaccine Provenge (sipuleucel-T) before an advisory panel, the FDA said Tuesday, in response to early rumors that a panel would be convened ahead of the May 1 PDUFA date

The PDUFA date is set for Oct. 30

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

The new PDUFA date is April 30, 2010