Pipeline Preview (December 2006) - - Formulary

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Pipeline Preview (December 2006)

Formulary

Approvable designations

  • Alvimopan (Entereg, Adolor, GlaxoSmithKline) for the treatment of postoperative ileus
  • Dextromethorphan and quinidine (Zenvia [formerly Neurodex], Avanir) for the treatment of involuntary emotional expression disorder
  • Darbepoetin alfa (Aranesp, Amgen) for the treatment of anemia in chronic kidney disease patients
  • Glutamine powder in UpTec for oral suspension (Saforis, MGI) for the treatment and prevention of oral mucositis
  • Paliperidone extended-release (Johnson & Johnson) for the treatment of schizophrenia

Nonapprovable designation

  • Faropenem medoxomil (Forest and Replidyne) for the treatment of certain bacterial infections

Fast-track designations

  • STA-4783 (Synta) for the treatment of metastatic melanoma
  • Homoharringtonine HHT (Ceflatonin, ChemGenex) for the treatment of chronic myeloid leukemia

Priority review
  • Lapatinib (Tykerb, GlaxoSmithKline) for the treatment of advanced breast cancer
  • Eculizumab (Soliris, Alexion) for the treatment of paroxysmal nocturnal hemoglobinuria
  • Adalimumab (Humira, Abbott) for the treatment of moderate-to-severe Crohn's disease
  • Fondaparinux sodium injection (Arixtra, GlaxoSmithKline) for the treatment of acute coronary syndromes

Orphan drug designations

  • Varicella zoster immune globulin (VariZIG, Cangene) for the passive immunization of individuals at risk of complications from varicella
  • MORAb-009 monoclonal antibody (Morphotek) for the treatment of pancreatic cancer
  • RTA 744 (Reata) for the treatment of malignant gliomas
  • Talactoferrin alfa (Agennix) for the treatment of renal cell carcinoma
  • KBPA101 monoclonal antibody (Kenta Biotech) for the treatment of nosocomial pneumonia

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