Lead Product(s) : Orphenadrine
Therapeutic Area : Musculoskeletal
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Orphenadrine Citrate-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2022
Lead Product(s) : Orphenadrine
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Orphenadrine,Aspirin,Caffeine
Therapeutic Area : Neurology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Opioid-free Pain Med Orphengesic Forte by Galt Pharmaceuticals Approved by FDA
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.
Product Name : Orphengesic Forte
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 16, 2020
Lead Product(s) : Orphenadrine,Aspirin,Caffeine
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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