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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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
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: ApprovedProduct 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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