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FDA February 2015 Products Receiving Orphan Designation

March 1, 2015






The chart below identifies FDA February 2015 Products Receiving Orphan Designation as of 03/01/15 in ascending “Orphan Drug Designation Date” order.

FDA February 2015 Products Receiving Orphan Designation

# Generic Name/ODD Date Sponsor Company Indication
1  N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide/ 02.03 Ignyta Inc. TrkA+, TrkB+, TrkC+, ROS1+ & ALK+ NSCLC
2 Antinuclear antibody conjugated liposomal doxorubicin/ 02.03 NanoSmart Pharmaceuticals Ewing’s Sarcoma
3 Bortezomib/ 02.03 Millennium Pharmaceutials Acute lymphoblastic leukemia
4 Saposin C/ 02.03 Bexion Pharmaceuticals Glioblastoma multiforme
5 Tisagenlecleucel-T/ 02.03 Novartis Diffuse large B-cell lymphoma
6 Copanlisib/ 02.05 Bayer HealthCare Follicular lymphoma
7 Ibrutinib/ 02.05 Pharmacyclics Splenic marginal zone lymphoma
8 Ibrutinib/ 02.05 Pharmacyclics Nodal marginal zone lymphoma
9 Tolerogen/ 02.05 Toleranzia AB (Switzerland) Myasthenia Gravis
10 Omeprazole-lansoprazoe with buffer/ 02.10 Effexus Pharmaceuticals Esophageal ulcers
11 Pelareorep/ 02.10 Oncolytics Biotech (Canada) Ovarian Cancer
12 5-[8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6yl]-2-pyrimidinamine/ 02.10 Verastem Malignant mesothelioma
13 Levomefolate calcium/ 02.10 Cox Biosciences Megaloblastic anemia caused by folate deficiency
14 Carboxy pyrrolidine hexanoyl pyrrolidine carboxylate/ 02.10 Glaxo Group Limited (UK) AL amyloidosis
15 Recombinant monoclonal antibody to human serum amyloid P component/ 02.10 Glaxo Group Limited (UK) AL amyloidosis
16 Paromomycin/ 02.11 The Surgeon General, Dept. of the Army Cutaneous leishmaniasis
17 3-pentylbenzenacetic acid sodium salt/ 02.11 ProMetic Life Sciences (Canada) Idiopathic pulmonary fibrosis
18 Glycyl-L-2-methylpropyl-L-glutamic acid / 02.11 Neuren Pharmaceuticals (New Zealand) Rett syndrome
19 Bivalent anti-human myostatin adnectin-IgG1/ 02.11 Bristol-Myers Squibb Duchenne muscular dystrophy
20 Recombinant humanized anti-interleukin 13 (IL-13) monoclonal antibody / 02.11 Receptos Inc. Eosinophilic esophagitis
21 Pelareorep/ 02.11 Oncolytics Biotech (Canada) Pancreatic Cancer
22 N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide/ 02.12 Ignyta Inc. TrkA+, TrkB+, TrkC+, ROS1+ & ALK+ Colorectal Cancer
23 Defactinib/ 02.12 Verastem Ovarian Cancer
24 Bovine Lactoferrin/ 02.19 Metrodora Therapeutics Late-onset sepsis in very low birth weight infants
25 Polidocanol/ 02.19 Provensis Ltd (UK) Congenital venous malformations
26 Naltrexone/ 02.23 Allodynic Therapeutics Postherpetic neuralgia
27 Andexanet Alfa/ 02.23 Portola Pharmaceuticals Reversing the anticoagulant effect of direct or indirect factor Xa inhibitors
28 Bovine Lactoferrin/ 02.23 Metrodora Therapeutics Prevention of necrotizing enterocolitis in very low birth weight infants
29 Rituximab/ 02.23 Genentech Pemphigus Vulgaris
30 Pelareorep/ 02.24 Oncolytics Biotech (Canada) Fallopian tube cancer
31 Pelareorep/ 02.24 Oncolytics Biotech (Canada) Primary Peritoneal Cancer
32 Deferasirox/ 02.24 Novartis Chronic iron overload in alpha-thalassemia
33 Acetylcysteine effervescent tablets for oral solution / 02.24 Arbor Pharmaceuticals Hepatic injury from acetaminophin overdose
34 Propranolol hydrochloride and etodolac / 02.24 Vicus Therapeutics Hepatocellular Carcinoma
35 Ketotifen/ 02.25 Melbourne Laboratories Mastocytosis


** Generic Name/ODD Date” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note : “Two small test tubes held in spring clamps” courtesy of  Amitchell125 at English Wikipedia [CC-BY-SA-30] | Wikimedia Commons.

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