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)