Physician Law Weekly
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Alamo Pharmaceuticals, LLC
FDA grants monthly WBC monitoring for FazaClo
June 15th, 2005
Alamo Pharmaceuticals' FazaClo (clozapine, USP) - a product for patients with treatment-resistant schizophrenia - may now offer monthly safety monitoring. Like all products containing the active ingredient clozapine, treatment with FazaClo is monitored prior to filling each prescription and refill in order to limit the risk of agranulocytosis, a rare but serious side effect that affects the blood. As each FazaClo patient's blood tests show acceptable white blood cell counts, the data is arrayed in the computerized FazaClo patient registry database, and the patient's pharmacist then releases the next prescription. This regulatory action shows expanded...
Source: Physician Law Weekly (2005-06-15)
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