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Orphan Drugs: FDA August 2014 Approvals

September 3, 2014

 

 

 

 

The chart below identifies Orphan Drugs receiving FDA August 2014 approval  as of 09/02/14 in ascending “Approval Date” order.

FDA August 2014 Orphan Products Receiving Approval

# Generic Name/Approval Date Sponsor Company Indication
1 Alglucosidase Alfa/ 08.01 * Genzyme Pompe Disease for patients of any age or phenotype
2 Eliglustat/ 08.19 Genzyme Gaucher Disease Type 1 For Adults who are CYP2D6 metabolizers detected by an FDA-cleared test
3 Eltrombopag/ 08.26 ** GlaxoSmithKline Severe Aplastic Anemia patients who have had an insufficient response to immunosuppressive therapy

.

* Supplement to expand the indication

** sNDA

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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