Orphan Drugs: FDA March 2015 Approvals
The chart below identifies Orphan Drugs receiving FDA March 2015 approval as of 04/09/15 in ascending “Approval Date” order.
FDA March 2015 Orphan Products Receiving Approval
|#||Generic Name/Approval Date||Sponsor Company||Indication|
|1||Isavuconazonium Sulfate/ 03.06||Astellas Pharma Global Development||Invasive Aspergillosis|
|2||Isavuconazonium Sulfate/ 03.06||Astellas Pharma Global Development||Invasive Mucomycosis|
|3||Dinutuximab/ 03.10||United Therapeutics Corporation||For use in combo with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) & 13-cis-retinoic acid (RA), for pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy|
|4||Cholic Acid (Cholbam)/ 03.17||Asklepion Pharmaceuticals||Bile acid synthesis disorders due to single enzyme defects|
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