The chart below identifies FDA May 2015 Products Receiving Orphan Designation as of 06/02/15 in ascending “Orphan Drug Designation Date” order.
FDA May 2015 Products Receiving Orphan Designation
# | Generic Name/ODD Date | Sponsor Company | Indication |
1 | Tacrolimus/ 05.04 | Stanford University School of Medicine | Pulmonary Arterial Hypertension |
2 | Tadalafil/ 05.04 | Eli Lilly & Co | Duchenne Muscular Dystrophy |
3 | Pantothenate Phosphate / 05.04 | Retrophin | Pantothenate Kinase Associated Neurodegeneration |
4 | Pelareorep/ 05.04 | Oncolytics Biotech | Gastric Cancer |
5 | 4-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one/ 05.04 | Gilead Sciences | Congenital Long QT Syndrome |
6 | LOAd703, a modified adenovirus 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand (TMZ-CD40L) and full length 4-1BBL/ 05.04 | Lokon Pharma AB (Sweden) | Pancreatic Cancer |
7 | Humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473)/ 05.05 | Janssen Research & Development | Acute Myeloid Leukemia |
8 | Autologous tumor cells… |
View original post 246 more words