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Evoltra is currently approved in Europe for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
The Opinion of the EMeA is also required to be adopted by the European Commission as a pre-condition to the grant of marketing authorization of Evoltra for this new indication.
Topics Covered Executive Summary Introduction Manufacturing sites Manufacturing site review, 2006 Products Leading Mayne Pharma Products, August 2006 Mayne Pharma ANDA approvals, 2002-06 Faulding Pharmaceutical ANDA approvals, 2002-03 Product Pipeline Innovative Product Distribution Deals Mayne acquires SuperGen's North American oncology products Mayne signs deal with Bioenvision for Evoltra Recent product approvals Recent Product Launches/Approvals Oxaliplatin approved in Germany Epirubicin injection Mitoxantrone injection Carboplatin Fluconazole injection Mayne launches paclitaxel in the EU Financial results Latest Yearly Results Financial Results, Fiscal 2005-06 Sales by Category, 2006 Major developments Mergers, acquisitions and agreements Hospira completes A$2.