FDA February 2015 Products Receiving Orphan Designation

 

 

 

 

 

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

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** 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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