[{"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"}]
Find Clinical Drug Pipeline Developments & Deals for Orphenadrine Citrate
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.
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.