Celgene Says REVLIMID Receives Conditional Marketing Authorisation Approval For Deletion 5q MDS In Canada - Quick Facts

(RTTNews) - Celgene Corporation (CELG | news | PowerRating | PR Charts ) announced the results of regulatory actions regarding REVLIMID in Australia in multiple myeloma or MM, and in Canada and the European Union in deletion 5q myelodysplastic syndromes or MDS.

In Australia, REVLIMID (lenalidomide) has received marketing authorisation approval from the Australian Therapeutic Goods Administration for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy.

In Canada, REVLIMID (lenalidomide) received conditional marketing authorisation approval from the Canadian Therapeutic Products Directorate (TPD | news | PowerRating | PR Charts ) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

In the European Union, the European Medicines Agency's (EMEA | news | PowerRating | PR Charts ) Committee for Medicinal Products for Human Use or CHMP issued a Negative Opinion on the Company's Marketing Authorisation Application for Lenalidomide - Celgene Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

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