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Orphan Drugs: FDA March 2015 Approvals

April 9, 2015

 

 

 

 

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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Please Note: “First Pigment Analysis (5893349712)” by NASA ICE (First Pigment Analysis Uploaded by russavia) [CC-BY-2.0] | Wikimedia Commons.

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