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Orphan Drugs: FDA December 2014 Approvals

January 14, 2015





The chart below identifies Orphan Drugs receiving FDA December 2014 approval as of 01/13/15 in ascending “Approval Date” order.

FDA December 2014 Orphan Products Receiving Approval

# Generic Name/Approval Date  Sponsor Company Indication
1 Blinatumomab(Blincyto)/ 12.03 Amgen Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
2 Ruxolitinib (Jakafi)/ 12.04 Incyte Corporation Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea
3 Denosumab (Xgeva)/ 12.05 Amgen Hypercalcemia of malignancy refractory to biphosphonate therapy
4 Aripiprazole (Abilify)/ 12.12 Otsuka Pharmaceutical Development & Commercialization Pediatric patients with Tourette’s disorder
5 Pasireotide (Signifor)/ 12.15 Novartis Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option
6 Lanreotide Acetate (Somatuline Depot)/ 12.16 Ipsen Biopharmaceuticals Unresectable,well- or moderately-differentiated locally advanced/metastatic gastroenteropancreatic neuroendocrine tumors
7 Olaparib (Lynparza)/ 12.19 AstraZeneca Monotherapy for deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
8 Nivolumab (Opdivo)/ 12.22 Bristol-Myers Squibb Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor


Please Note: “First Pigment Analysis (5893349712)” by NASA ICE (First Pigment Analysis Uploaded by russavia) [CC-BY-2.0] | Wikimedia Commons.

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