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Orphan Drugs: FDA April 2014 Approvals

May 3, 2014

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The chart below identifies orphan drug designated products receiving FDA approval in April 2014 (as of 05/03/14) in ascending “Approval Date” order.

FDA April 2014 Orphan Drugs Receiving Approval

Updated 05/04/14 with Ofatumumab (Arzerra).

 

#   Generic Name/Approval Date Sponsor Company Indication
1 ethiodized oil injection (Lipiodol)/ 04.04 Guerbet LLC Imaging tumors in adults with known hepatocellular carcinoma (HCC)
2 Ofatumumab (Arzerra)/ 04.17 Glao Group Limited chronic lymphocytic leukemia (CLL)
3 Ramucirumab (Cyramza)/ 04.21 Eli Lilly and Company Gastric Cancer or gastro-esophageal junction adenocarcinoma
4 Siltuximab (Sylvant)/ 04.23 Janssen Biotech Multicentric Castleman’s Disease (MCD)
5 Mercaptopurine/ 04.28 Nova Laboratories Limited (UK) Acute Lymphoblastic Leukemia (ALL)
6 Ceritinib (Zykadia)/ 04.29 Novartis Pharmaceuticals Corp ALK+ metastatic non-small cell lung cancer (NSCLC) who have progressed onor are intolerant

to crizotinib

 

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Please Note: FDA Official Logo from FDA website.

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