Search Orphan Drug Designations and Approvals
-
Generic Name: | Somatropin (rDNA) |
---|---|
Date Designated: | 05/03/1989 |
Orphan Designation: | For the enhancement of nitrogen retention in hospitalized patients suffering from severe burns. |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
EMD Serono, Inc. One Technology Place Rockland, Massachusetts 02370 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-