Galt Pharmaceuticals, Atlanta, GA, announced that the US Food & Drug Administration has issued a new drug approval for Orphengesic Forte, a non-opioid, non-controlled, non-addictive prescription pain medication. Orphengesic Forte is indicated for the relief of mild to moderate pain of acute musculoskeletal disorders, paired with rest, physical therapy, and other measures. The FDA approved the company’s Supplemental Abbreviated New Drug Application, over 2 months ahead of the scheduled goal date. The company expects to launch Orphengesic Forte in August 2020.
Each oral tablet contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg. Orphengesic Forte is contraindicated in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, obstructions at the bladder neck, myasthenia gravis, hypersensitivity to the drug, and known sensitivities to aspirin or caffeine. Patients with chicken pox, flu, or flu symptoms due to the possible development of Reye’s Syndrome should not take this drug. Common side effects are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents.
Additional safety information and the complete list of adverse reactions are contained in the full prescribing information, which can be found at http://orphengesicforte.com/stage/assets/documents/Orphengesic_Forte_500523-03_2020-07-10.pdf.