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          VOWSTVaccines, Blood & Biologics VOWST
  
  	
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    Print**STN:** 125757**Proper Name:** fecal microbiota spores, live-brpk**Tradename:** VOWST**Manufacturer:** Seres Therapeutics, Inc.**Indication:**

VOWST is indicated to prevent the recurrence of *Clostridioides difficile* infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).Product Information

Package Insert - VOWST
	Patient Information - VOWST
	Demographic Subgroup Information – fecal microbiota spores, live-brpk (VOWST)
	Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.Supporting Documents

April 26, 2023 Summary Basis for Regulatory Action - VOWST
	April 26, 2023 Approval Letter - VOWST
	Approval History, Letters, Reviews, and Related Documents - VOWST

                                                                                  Content current as of:
      05/18/2023
              
              
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)
          Guidance, Compliance & Regulatory Information (Biologics)
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          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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