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    [{"orgOrder":0,"company":"Braeburn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Braeburn Resubmits New Drug Application for BRIXADI","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Braeburn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI\u2122 (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Braeburn","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Braeburn Receives Complete Response Letter for the NDA for BRIXADI\u2122 (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Braeburn","sponsor":"Altruix","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Altruix Approved to Dispense Brixadi\u00ae for Moderate to Severe Opioid Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"}]

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              Altruix Approved to Dispense Brixadi® for Moderate to Severe Opioid Use Disorder

              Details:

              Under the partnership, Altruix has been selected as a limited distribution partner for Brixadi (buprenorphine), an opioid medication and an extended-release subcutaneous injection indicated for the treatment of moderate to severe opioid use disorder patients.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Altruix

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership August 17, 2023

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              FDA Accepts Braeburn's New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

              Details:

              BRIXADI is an investigational, extended-release SC injectable therapy under review by FDA for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 08, 2022

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              Braeburn

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              Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder

              Details:

              BRIXADI, SC injection, will be indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 02, 2022

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              Braeburn

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              Braeburn Resubmits New Drug Application for BRIXADI

              Details:

              BRIXADI is an investigational, extended-release injection for subcutaneous use that is under review by FDA for the treatment of moderate to severe opioid use disorder, and expects to receive a PDUFA date in 30 days.

              Lead Product(s): Buprenorphine

              Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 15, 2021

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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