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4Q approvals

4Q approvals

4Q approvals
Selected fourth quarter product approvals.
Company Approval
Amgen (NASDAQ:AMGN) EC grants marketing approval to Vectibix panitumumab for use as monotherapy to treat EGFR-expressing metastatic colorectal cancer with wild-type K-Ras (KRAS) genes after failure of standard chemotherapy. The approval is conditional as there is more evidence to come about the drug, including its safety and effectiveness in patients whose tumours contain non-mutated K-Ras.
Bayer (FSE:BAY)/Onyx (NASDAQ:ONXX) EC and FDA approve Nexavar sorafenib to treat hepatocellular carcinoma (HCC)
Biocon (NSE:BIOCON; BSE:BIOCON) India approves Abraxane paclitaxel to treat breast cancer
BioMarin (NASDAQ:BMRN; SWX:BMRN) FDA approves Kuvan sapropterin to treat phenylketonuria (PKU)
Fresenius SE (FSE:FRE) FDA approves Voluven hydroxyethyl to treat blood volume loss following surgery
Genzyme (NASDAQ:GENZ) FDA approves Renvela sevelamer carbonate to control serum phosphorus in dialysis patients with chronic kidney disease (CKD)
Genentech (NYSE:DNA)/ Roche (SWX:ROG) EC approves a label expansion for Avastin bevacizumab to include first-line treatment of advanced renal cell carcinoma (RCC) in combination with interferon
Gilead (NASDAQ:GILD)/ Bristol-Myers (NYSE:BMY) EC approves Atripla efavirenz/emtricitabine/tenofovir to treat HIV
Hospira (NYSE:HSP) EC approves Retacrit epoetin zeta to treat anemia associated with chronic renal failure and chemotherapy
ImClone (NASDAQ:IMCL)/ Bristol-Myers (NYSE:BMY) FDA approves an sBLA for Erbitux cetuximab for use as a single agent to treat metastatic colorectal cancer

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