FDA Orphan Drug Designations: 1st Quarter 2015 Approval Rate
The chart below compares the number of FDA Orphan Drug Marketing Approvals in the 1st Quarter of 2014 versus the number of FDA ODD Marketing Approvals in the 1st Quarter of 2015. The FDA’s Orphan Drug Product Designation Database Application is the source of the information.
FDA Orphan Drug 1st Quarter Approval Rate (2014 vs. 2015)
|# of Jan-Mar 2014 FDA ODD Approvals||# of Jan-Mar 2015 FDA ODD Approvals||% Change From 2014 To 2015|
Thus, there is no change in the # of FDA Orphan Drug Marketing Approvals in the 1st Quarter of 2014 compared to the # of FDA Orphan Drug Marketing Approvals in the 1st Quarter of 2015. This is in contrast to the increase in the # of 1st Quarter FDA ODDs of 2015 compared to 2014 – there is a 126% increase.
The chart below shows the 10 FDA ODD Marketing Approvals in the 1st Quarter of 2015, in ascending chronological order.
FDA Orphan Drug Approvals for 1st Quarter 2015 (January-March)
|Brand/Generic Name||Orphan Designation||Marketing Approval Date||Sponsor|
|Duodopa (Levodopa & Carbidopa)||Motor Fluctuations in Advanced Parkinson’s Disease||01.09.15||AbbVie|
|Phoxilium||Replacement solution in Continuous Renal Replacement Therapy (CRRT) & in case of drug poisoning when CRRT is used to remove dialzable substances||01.13.15||Gambro Renal Products|
|Natpara (Parathyroid Hormone)||Hypoparathyroidism||01.23.15||NPS Pharmaceuticals|
|Imbruvica (Ibrutinib)||Waldenstrom’s Macroglobulinemia||01.29.15||Pharmacyclics|
|Lenvima (Lenvatinib)||Locally recurrent/metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer||02.13.15||Eisai|
|Farydak (Panobinostat)||Multiple Myeloma||02.23.15||Novartis Pharmaceuticals|
|Isavuconazonium Sulfate||Invasive Mucormycosis||03.06.15||Astellas Pharma|
|Isavuconazonium Sulfate||Invasive Aspergillosis||03.06.15||Astellas Pharma|
|Dinutuximab||In combination with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), IL-2 & 13-cis-retinoic acid (RA) For pediatric high-risk neuroblastoma||03.10.15||United Therapeutics Corporation|
|Cholbam (Cholic Acid)||Bile acid synthesis disorders due to single enzyme defects||03.17.15||Asklepion Pharmaceuticals|
Please Note: “Interferon” courtesy of Linda Bartlett (Photographer) from the National Cancer Institute (NCI). [Public domain in the US].