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Schering-Plough Receives EU and US Approvals for Intravenous Formulation of Temozolomide

Thu, 03/05/2009 - 3:44am
Schering-PloughCorporation today announced that the European Commission and theUS FDA both approved the intravenous (IV) formulation of temozolomide as analternative to the already approved oral form of the drug. Temozolomide ismarketed as TEMODAL(R) in the EU and as TEMODAR(R) in the US. The EUCommission Decision was based on the positive opinion from the EuropeanCommittee for Medicinal Products for Human Use (CHMP) of the EuropeanMedicines Agency (EMEA) in November 2008. On January 22, 2009, the Commissionapproved a sachet packaging presentation for TEMODAL Capsules. This newpresentation provides greater patient convenience and flexibility. On February17, 2009, the Commission approved an IV formulation of TEMODAL. On February27, 2009, Schering-Plough received approval from the US FDA for the TEMODAR IVformulation. TEMODAL is a chemotherapy agent approved in the EU for treatment ofpatients with newly diagnosed glioblastoma multiforme (GBM) concomitantly withradiotherapy and subsequently as monotherapy, and for patients with malignantgliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence orprogression after standard therapy. In the US, TEMODAR is approved for thetreatment of adult patients with newly diagnosed GBM concomitantly withradiotherapy and then as maintenance treatment, as well as for refractory AA,i.e., patients who have experienced disease progression on a drug regimencontaining nitrosourea and procarbazine. "TEMODAR is a well recognized, effective treatment for patients with newlydiagnosed GBM. The newly approved IV formulation of TEMODAR provides patientswith an important alternative method of administration, and the EuropeanTEMODAL sachet presentation offers flexibility and a convenient alternativeform of packaging," said Robert J. Spiegel, M.D., chief medical officer andsenior vice president, Schering-Plough Research Institute. "These two newoptions recognize Schering-Plough's commitment to providing effectivetreatments in a variety of presentations for specific patient needs andpatient convenience."
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