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FDA September 2013 Products Receiving Orphan Designation (Part 2)

October 3, 2013

There are 42 products receiving FDA Orphan Designation for September 2013 – the most of any month for 2013. Because of the large number of Orphan Designations, the list is split into 2 charts in 2 Blog Posts.

The chart below identifies the FDA September 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of October 1, 2013. The chart is created by performing a search for the following date range:

Start Date: 09/01/2013 & End Date: 09/31/2013.

Row Num

Generic Name

Designation Date

Orphan   Designation

22

                                                                      denosumab 09-11-2013 Hypercalcemia of Malignancy

23

     dimethyl   fumarate 09-11-2013 Friedreich’s Ataxia

24

     dovitinib 09-26-2013 Adenoid Cystic Carcinoma

25

     ethiodized   oil injection 09-26-2013 Diagnostic for the management of patients with   hepatocellular carcinoma

26

     fenretinide 09-04-2013 Cutaneous T-Cell Lymphoma

27

     fenretinide 09-04-2013 Peripheal T-Cell Lymphoma

28

     human   glial restricted progenitor cells and their progeny 09-11-2013 Amyotrophic Lateral Sclerosis

29

     human   monoclonal IgG2 to human proprotein convertase subtilisin/kexin type 9 09-12-2013 Homozygous Familial Hypercholesterolemia

30

     idelalisib 09-26-2013 Lymphoplasmacytic Llymphoma

31

     idelalisib 09-26-2013 Follicular Lymphoma

32

     lenalidomide 09-13-2013 Follicular Lymphoma

33

     listeria   monocytogenes 09-05-2013 Pancreatic Cancer

34

     manganese   (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of   absorption) 09-26-2013 Targeted Contrast Agent for Diagnostic MRI for the   detection and localization of focal liver

35

     melarsoprol-hydroxypropylbetadex 09-13-2013 Human African Trypanosomiasis (Sleeping Sickness)

36

     melphalan   hydrochloride 09-26-2013 Hepatocellular Carcinoma

37

     riociguat 09-19-2013 Pulmonary Arterial Hypertension

38

     selective   antagonist of the chemokine receptor type 4 09-05-2013 Acute Myeloid Leukemia

39

     self-complimentary   adeno-associated virus vector, serotype 9, packaging the full lenght GAN gene   in the viral capsid 09-27-2013 Giant Axonal Neuropathy

40

     sodium   sulfate, potassium sulfate, and magnesium sulfate; PEG-3350, sodium chloride,   sodium bicarbonate and potassium chloride 09-04-2013 Cleansing of the Colon in preparation for colonoscopy

41

     ublituximab 09-05-2013 Nodal Marginal Zone Lymphoma

42

     ublituximab 09-05-2013 Extranodal Marginal Zone Lymphoma

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

Please Note: “DNA Purification” Courtesy of Dr. Bruce Chassey Laboratory. National Institute Of Dental Research. Li-shan. NCI [Public domain in the US].

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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