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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
| # | 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 | Ramucirumab (Cyramza)/ 04.21 | Eli Lilly and Company | Gastric Cancer or gastro-esophageal junction adenocarcinoma |
| 3 | Siltuximab (Sylvant)/ 04.23 | Janssen Biotech | Multicentric Castleman’s Disease (MCD) |
| 4 | Mercaptopurine/ 04.28 | Nova Laboratories Limited (UK) | Acute Lymphoblastic Leukemia (ALL) |
| 5 | Ceritinib (Zykadia)/ 04.29 | Novartis Pharmaceuticals Corp | ALK+ metastatic non-small cell lung cancer (NSCLC) who have progressed onor are intolerant
to crizotinib |
.
Please Note: FDA Official Logo from FDA website.
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