• Safety & Recalls
  • Regulatory Updates
  • Drug Coverage
  • COPD
  • Cardiovascular
  • Obstetrics-Gynecology & Women's Health
  • Ophthalmology
  • Clinical Pharmacology
  • Pediatrics
  • Urology
  • Pharmacy
  • Idiopathic Pulmonary Fibrosis
  • Diabetes and Endocrinology
  • Allergy, Immunology, and ENT
  • Musculoskeletal/Rheumatology
  • Respiratory
  • Psychiatry and Behavioral Health
  • Dermatology
  • Oncology

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


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

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