FDA Pipeline Preview, March 2012 (ViroPharma, Novartis, Amgen, Del Mar Pharmaceuticals, CSL Behring, Genentech, Salix, Gilead, Pfizer, Repligen)

March 1, 2012

Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate

Complete response

Not recommended for approval

Orphan drug designations