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FDA Orphan Drug Designations: 1st Quarter 2015 Approval Rate

April 12, 2015



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
10 10 0 %


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].

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