Orphan Drugs: FDA December 2014 Approvals
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|
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