and Pfizer Inc., both of New York, said the FDA extended the PDUFA date for their new drug application (NDA) for Eliquis (apixaban) by three months to June 28
Tafimidis, which Pfizer gained through its 2010 acquisition of privately held FoldRx Pharmaceuticals Inc., of Cambridge, Mass., was granted a priority review and has a PDUFA date in June 2012
Gilead Sciences Inc., of Foster City, Calif., said the FDA accepted its supplemental new drug application and granted a six-month priority review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, setting a PDUFA date of June 15
Alexza resubmitted the application, which is set for FDA review by a May 4 PDUFA date, and an advisory panel voted 9-8 in favor of the drug last year. (See BioWorld Today, Oct. 12, 2010, and Dec. 13, 2011...The agency has set a PDUFA date of July 26
The drug has a PDUFA date of June 27. (See BioWorld Today, Oct. 26, 2010, and Jan. 12, 2012...Last year, the company submitted a new drug application (NDA) for Lymphoseek to the FDA, which accepted the filing in October and scheduled a PDUFA date of June 10, 2012
Alexza Pharmaceuticals Inc., of Mountain View, Calif., said the FDA extended the PDUFA date of its new drug application (NDA) for Adasuve (Staccato loxapine) from Feb. 4 to May 4
Amgen submitted the sBLA for Xgeva's second indication on June 27, 2011, and the application has a PDUFA date of Apr. 26, 2012. (See BioWorld Today, Nov. 22, 2010, and Sept. 16, 2011...The application has a PDUFA date of March 28, 2012. (See BioWorld Today, Sept. 29, 2011
In other news, Boehringer said it randomized the final patient to treatment in its Phase III program of BI 201335, an oral protease inhibitor for chronic hepatitis C virus...Santarus has licensed certain exclusive rights from Pharming to commercialize Rhucin in North America for the treatment of acute attacks of HAE and other future indications
BioWorld International | Wednesday, December 14, 2011
with Eisai Inc., of Woodcliff Lake, N.J., is under review at the FDA, with a PDUFA date of June 27