FDA Actions in Brief (December 2006) - - Formulary

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FDA Actions in Brief (December 2006)

Formulary

Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.

FDA approved trastuzumab (Herceptin, Genentech) as part of a treatment regimen for the adjuvant treatment of HER2-positive breast cancer in women who have undergone surgery.

Nitroglycerin lingual aerosol (NitroMist, NovaDel) was approved for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Adalimumab (Humira, Abbott) was approved for the treatment of structural joint damage in patients with psoriatic arthritis.

Quetiapine fumarate (Seroquel, AstraZeneca) was approved for the treatment of depressive episodes associated with bipolar disease.

Docetaxel (Taxotere, Sanofi-Aventis) was approved for the treatment of head and neck cancer.

Risperidone (Risperdal, Johnson & Johnson) was approved for the treatment of irritability associated with autistic disease.

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