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12:00 AM
Jan 02, 2006
 |  BioCentury  |  Finance

4Q approvals

4Q approvals

4Q approvals
Selected fourth quarter product approvals. Does not include approvable letters for Vivitrol naltrexone to treat alcohol dependence from Alkermes (ALKS) and Cephalon (CEPH); Daytrana methylphenidate transdermal system for pediatric ADHD from Shire (LSE:SHP; SHPGY) and Noven (NOVN); an sNDA for Thalomid to treat multiple myeloma (MM) from Celgene (CELG); and an sNDA for Sparlon modafinil from CEPH to treat ADHD. While not full approvals, the letters did not ask for major data.
Company Approval
Amgen (AMGN) Europe approves Kepivance palifermin to treat oral mucositis in hematologic cancer patients undergoing high dose chemotherapy followed by bone marrow transplant
Bayer (FSE:BAYG; BAY)/Onyx (ONXX) FDA approves Nexavar sorafenib to treat advanced renal cell carcinoma (RCC)
Bristol-Myers (BMY) FDA approves Orencia abatacept to treat rheumatoid arthritis (RA)
Celgene (CELG) FDA approves Revlimid lenalidomide to treat myelodysplastic syndromes (MDS) with 5q chromosomal deletion
Epix (EPIX)/ Schering...

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