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12:00 AM
Apr 02, 2007
 |  BioCentury  |  Finance

1Q approvals

1Q approvals

1Q approvals
Selected first quarter product approvals
Company Approval
Abbott (ABT) FDA approves an sBLA for Humira adalimumab to treat moderate to severe Crohn's disease in patients not responding to conventional therapy
Alexion (ALXN) FDA approves Soliris eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH)
Barrier (BTRX) Canada approves Xolegel ketoconazole to treat seborrheic dermatitis in immunocompetent adults and children ages 12 and older
Bayer (FSE:BAY; BAY) FDA approves Yaz ethinyl estradiol/drospirenone to treat moderate acne in women who want an oral contraceptive for birth control
Celera (CRA)/Abbott (ABT) Canada approves the companies' RealTime HCV and RealTime HIV-1 viral load assays as an indicator of disease prognosis and to aid in the management of patients undergoing antiviral therapy
Cepheid (CPHD) FDA grants 510(k) clearance for the company's Xpert EV lab test to detect enterovirus (EV) associated meningitis
Cerus (CERS) France approves the Intercept Blood System to reduce the risk of transfusion-transmitted diseases in plasma. Germany approves the sale of platelets treated with Intercept Blood System by a blood center at the University Hospital Schleswig-Holstein.
Eisai (Tokyo:4523; Osaka:4523)/Novartis (NVS; SWX:NOVN) EC approves Inovelon rufinamide as adjunctive therapy to treat seizures associated with Lennox Gastaut syndrome in children ages 4 and up
Encysive (ENCY) Australia approves Thelin sitaxentan to treat pulmonary arterial hypertension
Genentech (DNA)/Novartis (NVS; SWX:NOVN) EC approves Lucentis ranibizumab to treat wet age-related macular degeneration (AMD)
Genentech (DNA)/OSI (OSIP) EC approves an expanded label for Tarceva erlotinib to treat metastatic pancreatic cancer in combination with gemcitabine
Genentech (DNA)/Roche (SWX:ROG) EC approves an MAA to expand the label of Avastin bevacizumab to include first-line treatment of patients with...

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