Search Orphan Drug Designations and Approvals
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Generic Name: | alendronate |
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Date Designated: | 03/31/2003 |
Orphan Designation: | Treatment of osteogenesis imperfecta in pediatric patients 4 years of age and older |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Merck, Sharpe & Dohme Corp. 126 East Lincoln Ave. RY 33-212 Rahway, New Jersey 07065 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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