Orphan Drugs: FDA April 2014 Approvals
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
Please Note: FDA Official Logo from FDA website.