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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: buprenorphine
Date Designated: 05/25/2022
Orphan Designation: Treatment of opioid withdrawal syndrome in the pediatric population
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
Parma 43122

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.