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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
Are PBMs Putting GLP-1 Drugs on Their Formularies?
October 11th 2024PBMs are putting weight loss drugs, including Wegovy and Zepbound, on their national formularies, but coverage by plans is uneven. What is needed is more data about whether these drugs can lower overall healthcare costs.
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