The PDUFA date originally was July 28

MGI Pharma Inc., of Minneapolis, said the FDA accepted its new drug application for Saforis (glutamine in UpTec) Powder for Oral Suspension for priority review, and a PDUFA date was set for Oct. 12

The FDA established a PDUFA date of Nov. 9

Neurochem Ltd., of Ecublens, Switzerland, a wholly owned subsidiary of Laval, Quebec-based Neurochem Inc., completed the filing of its new drug application for Fibrillex (eprodisate) for amyloid A amyloidosis, and the FDA granted priority review for the application, setting a PDUFA date of Aug. 13

Neurochem Ltd., of Ecublens, Switzerland, a wholly owned subsidiary of Laval, Quebec-based Neurochem Inc., completed the filing of its new drug application for Fibrillex (eprodisate) for amyloid A amyloidosis, and the FDA granted priority review for the application, setting a PDUFA date of Aug. 13

Noven Pharmaceuticals Inc., of Miami, said the FDA assigned an April 9 PDUFA date to complete its review of the company’s new drug application for Daytrana (methylphenidate transdermal system) in attention deficit hyperactivity disorder

The PDUFA date is June 30

A new drug application for Oracea was filed with the FDA last August and has a PDUFA date of May 31

The PDUFA date for arformoterol is Oct. 12

To complete review of the driving study and the combined package insert, the FDA has advised that the PDUFA dates for the IR and MR are May 15 and June 27, respectively

The PDUFA date is set for Jan. 27, 2006

The original PDUFA date had been set for late October

The drug's original PDUFA date was Oct. 7

Cephalon Inc., of Frazer, Pa., and Alkermes Inc., of Cambridge, Mass., received notification from the FDA that the PDUFA date for Vivitrex, a naltrexone long-action injection for the treatment of alcohol dependence was extended to Dec. 30

A new drug application for Thelin also is under review in the U.S., with a PDUFA date of March 24, 2006

Celgene Corp. , of Summit, N.J., said the FDA granted priority review to its new drug application for its immunomodulatory drug Revlimid, with a PDUFA date of Oct. 7

CV Therapeutics Inc. , of Palo Alto, Calif., and Solvay Pharmaceuticals Inc., of Marietta, Ga., said the FDA extended the PDUFA date for the Aceon (perindopril erbumine) tablets supplemental new drug application by 90 days to allow additional time for clinical site audit activities...The PDUFA date now is Sept

Tercica said the decision was based on the FDA's extension of Insmed's PFUFA date to Oct. 3, which will come after Tercica's PDUFA date set for Aug. 31

Insmed Inc. , of Richmond, Va., received notification from the FDA that the agency expects to complete the priority review of SomatoKine on or before Oct. 3 marking a three-month extension from the original PDUFA date