Skip to content

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.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: