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Company
Product
Description
Indication
Action
Anthra Pharmaceuticals Inc.*
Valstar
Valrubicin (injected directly into bladder)
Treatment of aggressive, recurring, spreading bladder cancer (2nd-line therapy)
FDA Advisory Committee voted not to recommend approval (studies not rigorous enough to prove drug helped patients) (6/1)
The Medicines Co.*
Hirulog
Synthetic thrombin inhibitor based on hirudin (natural anti-coagulant secreted by leeches)
Anticoagulant for use in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty
FDA¿s Cardiovascular and Renal Drugs Advisory Committee voted 4 to 3 not to recommend approval (10/23)
Unimed Pharmaceuticals Inc.
Cryptaz (a.k.a. NTZ)
Nitazoxanide; a nitrothiazole compound with activity against many protozoan and helminthic pathogens (oral dosage)
Cryptosporidial diarrhea in AIDS patients (caused by Cryptosporidium parvum)
FDA¿s Antiviral Drugs Advisory Committee requested additional information before deciding whether to recommend (drug not compared to placebo) (5/6)
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