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FDA March 2013 Products Receiving Orphan Designation

April 2, 2013

The chart below identifies the FDA March 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of April 2, 2013. The chart is created by performing a search for the following date range :

Start Date: 03/01/2013 & End Date: 03/31/2013.

Generic   Name

Designation   Date

Orphan     Designation

1) 3-bromopyruvate 03-05-2013 Liver   & Intrahepatic Bile Duct Cancer
2) 40K   PEGylated recombinant factor IX 03-18-2013 Prophylactic   administration for prevention of bleeding in patients with hemophilia B
3) AAV-G6Pase   vector 03-11-2013 Glycogen   Storage Disease Type Ia
4) C66H100NO27 03-11-2013 Hepatocellular   Carcinoma
5) His-His-Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr 03-11-2013 Retinal   Detachment
6) N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide   dihydrochloride monohydrate 03-21-2013 Polycythemia   Vera
7) Acamprosate 03-25-2013 Fragile   X Syndrome
8) Aerosolized   beractant 03-11-2013 Respiratory   Distress Syndrome
9) Autologous   CD34+ hematopoietic stem cells transduced with LentiGlobin BB305   lentiviral vector encoding the human BA-T87Q-globin gene 03-18-2013 B-thalassemia   Major & Intermedia
10) Cell   based therapeutic composed of allogeneic donor   apoptotic cells 03-18-2013 Prevention   of graft versus host disease
11) Chimeric   monoclonal antibody against Claudin 6 03-18-2013 Ovarian   Cancer
12) Inotuzumab   ozogamicin 03-25-2013 B-cell   Acute Lymphoblastic Leukemia
13) Liposomal   amikacin 03-25-2013 Infections   caused by non-tuberculous mycobacteria
14) Neostigmine 03-18-2013 Acute   Colonic Pseudo-Obstruction
15) Plasminogen   (human) 03-05-2013 Hypoplasminogenemia,   or Type I Plasminogen Deficiency
16) Recombinant   adenovirus vector AAV2/rh8 expressing human B-hexosaminidase A & B   subunits 03-25-2013 Tay-Sachs   Disease
17) Recombinant   elafin 03-18-2013 Prevention   of inflammatory complications of transthoracic sophagectomy
18) Recombinant   fusion protein consisiting of a modified form of extracellular domain of   human Activin receptor IIB 03-18-2013 Myelodysplastic   Syndrome
19) Recombinant   fusion protein consisting of a modified form of the extracellular domain   of human activin receptor IIB (ActRIIB) linked to a human IgG1 Fc domain 03-11-2013 B-Thalassemia
20) Recombinant   human Naglu- insulin-like growth factor II 03-05-2013 Mucopolysaccharidosis   type IIIB (Sanfilippo Syndrome Type   B)
21) Sirolimus 03-18-2013 Pachyonychia   Congenita
22) Transforming   growth factor-beta receptor 1 kinase inhibitor 03-11-2013 Glioma
23)   Neridronate 03-25-2013 Complex   Regional Pain Syndrome (CRPS)
24) Recombinant   adeno- associated virus vector AAV2/rh8 expressing human B-hexosaminidase A   and B subunits 03-25-2013 Sandhoff   Disease

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

Please Note: FDA Official Logo from FDA website.

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