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          CBER 2022 Orphan Approvals (new BLAs)Vaccines, Blood & Biologics CBER 2022 Orphan Approvals (new BLAs)
  
  	
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    PrintThis list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.

Trade Name/Proper Name
			Indication
			Manufacturer/License Number
			Approval Date**REBYOTA**
			Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
			Ferring Pharmaceuticals Inc.
			11/30/2022**HEMGENIX**
			Indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
			CSL Behring LLC
			11/22/2022**SKYSONA**
			Indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
			bluebird bio, Inc.
			09/16/2022**ZYNTEGLO**
			Indicated for the treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions.
			bluebird bio, Inc.
			08/17/2022***CARVYKTI***
			Is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
			Janssen Biotech, Inc.
			02/28/2022

                                                                                  Content current as of:
      08/28/2023
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
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          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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