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FDA Pipeline preview, July 2008


Recent FDA action (through July 2008) related to tigecycline, bazedoxifene, balsalazide tablet, tacrolimus, fospropofol injection, bivalirudin, 13-valent pneumococcal conjugate vaccine, pirfenidone, LX1032, palifosfamide, SB1518, oral tetrathiomolybdate, and terguride.

Approvable designations

Tigecycline (Tygacil, Wyeth) for the treatment of community-acquired pneumonia

Bazedoxifene (Wyeth) for the treatment of postmenopausal osteoporosis

Tacrolimus (FK506 modified release, Astellas) for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants (fourth approvable letter)

Recommended for approval

Fospropofol injection (Eisai/MGI) for sedation in adult patients undergoing diagnostic or therapeutic procedures

Nonapprovable designation

Bivalirudin (Angiomax, The Medicines Company) for the treatment of acute coronary syndromes initiated in the emergency department

Fast-track designations

13-valent pneumococcal conjugate vaccine (Wyeth) for active immunization of infants and toddlers against invasive pneumococcal disease and otitis media

Pirfenidone (InterMune) for the treatment of idiopathic pulmonary fibrosis

LX1032 (Lexicon) for the management of gastrointestinal symptoms associated with carcinoid syndrome

Priority review

Immune globulin intravenous (human), 10% caprylate/chromatography purified (Gamunex, Talecris) for the treatment of chronic inflammatory demyelinating polyneuropathy

Orphan drug designations

Palifosfamide (Ziopharm) for the treatment of soft tissue sarcoma

S±518 (S*Bio) for the treatment of myeloproliferative disorders

Oral tetrathiomolybdate (Pipex) for the treatment of idiopathic pulmonary fibrosis

Terguride (Ergonex) for the treatment of pulmonary arterial hypertension

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