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Approvable designations

• Fondaparinux injection (Arixtra, GlaxoSmithKline) for the treatment of patients with unstable angina or non-ST segment elevation myocardial infarction or with ST-segment elevation myocardial infarction

• Desvenlafaxine (Pristiq, Wyeth) for the treatment of adults with major depressive disorder

• Tacrolimus (FK506 modified release, Astellas) for the prophylaxis of organ rejection in kidney transplant and liver transplant patients

Recommendation for approval

• Combination vaccine (Pentacel, Sanofi-Aventis) for the prevention of diphtheria, pertussis, polio, tetanus, and Haemophilus influenzae type b (Hib)

Nonapprovable designation

• Tacrolimus (FK506 modified release, Astellas) for the prophylaxis of organ rejection in heart transplant patients

Fast-track designations

• Lumiliximab (Biogen Idec) for the treatment of chronic lympho-cytic leukemia

• SQ109 (Sequella) for the treatment of pulmonary tuber-culosis (TB)

Priority review

• Enoxaparin injection (Lovenox, Sanofi-Aventis) for the treatment of patients with acute ST-segment elevation myocardial infarction

• Sipuleucel-T (Provenge, Dendreon) for the treatment of asymptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer

Orphan drug designations

• Lumiliximab (Biogen Idec) for the treatment of chronic lympho-cytic leukemia

• Ranpirnase (Onconase, Alfacell) for the treatment of malignant mesothelioma

• Droxidopa (Chelsea Therapeutics) for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure

• Sodium stibogluconate (VQD-001, VioQuest in partnership with US Army) for the treatment of the cutaneous form of leishmaniasis

• Defibrotide (Gentium) for the prevention of hepatic veno-occlusive disease

• Vincristine liposomes injection (Marqibo, Hana Biosciences) for the treatment of adult patients with acute lymphoblastic leukemia

• Inhaled liposomal formulation of ciprofloxacin (Aradigm) for the management of bronchiectasis

• LX211 (Lux Biosciences) for the treatment of noninfectious posterior, intermediate, and panuveitis

• LX201 (Lux Biosciences) for the prevention of rejection in corneal transplantation

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