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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
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
