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FDA May 2013 Products Receiving Orphan Designation

June 3, 2013

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

Start Date: 05/01/2013 & End Date: 05/31/2013.

Row Num

Generic Name

Designation Date

Orphan   Designation

1

                                                                      2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indian-2-carboxylic acid 05-14-2013 Systemic Sclerosis

2

3,5-diiodothyropropionic acid 05-14-2013 Allan-Herndon-Dudley Syndrome

3

DCVAC OvCa 05-14-2013 Ovarian Cancer

4

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-alys-aleu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH 05-14-2013 Subarachnoid Hemorrhage

5

HIRMAb-IDS 05-15-2013 Mucopolysaccharidosis Type II (Hunter Syndrome)

6

N-{3-[(2-{[4-(4-acetylpiperazin-l-yl)-2-methoxyphenyl]amino}-5-(trifluoromethyl)pyrimidin-4-yl)amino]phenyl}prop-2-enamide 05-14-2013 Non-Small Cell Lung Cancer (NSCLC)

7

Abatacept 05-30-2013 Type I Diabetes Mellitus with Residual Beta Cell Function

8

Adeno associated viral vector serotype rh.10 carrying the   human SGSH & SUMF1 cDNAs 05-06-2013 Mucopolysaccharidosis Type IIIA (Sanfilippo Type A Syndrome)

9

Budesonide 05-06-2013 Ulcerative Colitis in pediatric patients, ages 0 – 16

10

Daratumumab 05-06-2013 Multiple Myeloma

11

Diazepam auto-injector 05-30-2013 Epilepsy Pats on stable regimens of Antiepileptic Drugs   (AEDs), who require intermittent use of Diazepam

12

Hepatitis B virus neutralizing human monoclonal antibody 05-06-2013 Prevention of Hepatitis B Recurrence following liver   transplantation

13

Ibrutinib 05-16-2013 Multiple Myeloma

14

Ibrutinib 05-30-2013 Small Lymphocytic Lymphoma

15

Isavuconazonium Sulfate 05-06-2013 Invasive Aspergillosis.

16

Modified recombinant human Factor VIIa (rFVIIa) molecule 05-30-2013 Bleeding episodes in Hemophilia A or B with inhibitors

17

Pazopanib 05-06-2013 Ovarian Cancer

18

Pexastimogene Devacirepvec 05-06-2013 Hepatocellular Carcinoma

19

Recombinant fusion protein linking coagulation factor VIIa   with albumin (rVIIa-FP) 05-06-2013 Congenital Factor VII Deficiency

20

Replication-deficient recombinant serotype 2 adeno-associated viral vector containing hAQP1 cDNA 05-03-2013 Grade 2 & Grade 3 Late Xerostomia from Parotid Gland Hypofunction

21

Teprotumumab 05-06-2013 Active (Dynamic) Phase Grave’s Orbitopathy

22

Terguride 05-17-2013 Systemic Sclerosis

23

Zoledronic acid 05-06-2013 Complex Regional Pain Syndrome (CRPS).

** “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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