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FDA April 2013 Products Receiving Orphan Designation

May 6, 2013

The chart below identifies the FDA April 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of May 6, 2013. The chart is created by performing a search for the following date range :

Start Date: 04/01/2013 & End Date: 04/30/2013.

Row Num

Generic Name

Designation Date

Orphan   Designation

1

                                                                      (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one 04-15-2013 Chronic Lymphocytic Leukemia & Small Lymphocytic Lymphoma

2

     4-(6-(4-(piperazin-1-yl)phenyl_pyrazolo[1,5-a]pyrimidin-3-yl)quinoline   hydrochloride 04-15-2013 Fibrodysplasia Ossificans Progressiva

3

     Kre-Celazine 04-01-2013 Juvenile Rheumatoid Arthritis joint & related tissue inflammation

4

    Anti-Inhibitor Coagulant Complex 04-12-2013 Routine prophylaxis to prevent or reduce frequency of bleeding episodes in hemophilia A and B patients with inhibitors

5

     Brentuximab Vedotin 04-15-2013 Peripheral T-Cell Lymphoma

6

     Daunorubicin Citrate Liposome 04-15-2013 Acute Myeloid Leukemia

7

     Givinostat 04-12-2013 Duchenne Muscular Dystrophy & Becker   Muscular Dystrophy

8

     Melatonin 04-12-2013 Neonatal Hypoxic Ischemic Encephalopathy

9

     Methylparaben Suberohydroxamic Acid Phenyl Ester 04-15-2013 Cutaneous T-Cell Lymphoma

10

     Opioid Growth Factor 04-16-2013 Liver & Intrahepatic Bile Duct Cancer

11

     Recombinant Human Alpha-N-Acetylglucosaminidase 04-15-2013 Mucopolysaccharidosis IIIB (Sanfilippo B   Syndrome)

12

     Recombinant Human Tripeptidyl-Peptidase 1 (rhTPP1) 04-01-2013 Neuronal Ceroid Lipofuscinosis Type 2

13

     Recombinant Humanized IgG1k Monoclonal Antibody to Human Invariant T Cell receptor (iTCR) 04-12-2013 Sickle Cell Disease

14

     SdTD-K6a.513a.12; Small Interfering RNA composed of 2 strands of hybridized RNAs 04-15-2013 Pachyonychia Congenita

15

     Sodium Ascorbate & Menadione Sodium Bisulfite 04-15-2013 Autosomal Dominant Polycystic Liver Disease

16

     Sodium Ascorbate & Menadione Sodium Bisulfite 04-15-2013 Autosomal Dominant Polycystic Kidney Disease

17

     Tocilizumab 04-17-2013 Systemic Sclerosis

18

     Transforming Growth Factor-Beta Receptor 1 Kinase Inhibitor 04-01-2013 Hepatocellular Carcinoma

** “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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