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FDA October 2013 Orphan Designations Receiving Approval

November 4, 2013

A New Feature: Starting this month, a new feature,  a monthly “FDA 2013 Orphan Designations Receiving Approval” Blog Post will appear along with the monthly “FDA 2013 Products Receiving Orphan Designation” Blog Post.

The chart below identifies the 3 Orphan Designations receiving FDA October 2013 approval for the month. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of November 4, 2013.

Row Num

Generic Name

Designation Date

Orphan   Designation

Marketing   Approval Date

1

Macitentan 09-03-2009 Pulmonary Arterial Hypertension 10-18-2013

2

Riociguat 09-19-2013 Chronic Thromboembolic Pulmonary Hypertension 10-08-2013

3

Riociguat 09-19-2013 Pulmonary Arterial Hypertension 10-08-2013

**  “Generic Name” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note: “Erlenmeyer Flasks” From Argonne US National Lab  [Public domain in the US] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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