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[{"orgOrder":0,"company":"Galt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Opioid-free Pain Med Orphengesic Forte by Galt Pharmaceuticals Approved by FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"}]

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            Details:

            Orphenadrine Citrate recalled, because of the presence of a nitrosamine impurity, has potential to be above the U.S. FDA’s acceptable daily intake limit of 26.5 ng/day, was detected in the lots during recent testing.

            Lead Product(s): Orphenadrine

            Therapeutic Area: Musculoskeletal Product Name: Orphenadrine Citrate-Generic

            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 March 22, 2022

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            Details:

            U.S. Food and Drug Administration approved the company’s Supplemental Abbreviated New Drug Application for Orphengesic Forte, over two months ahead of the scheduled goal date.

            Lead Product(s): Orphenadrine,Aspirin,Caffeine

            Therapeutic Area: Neurology Product Name: Orphengesic Forte

            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 July 16, 2020

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