.
.
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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