Alkem debuts generic Duexis
This is the first Food and Drug Administration approval of generic Duexis tablets, the company said.
Alkem is introducing ibuprofen and famotidine tablets in a dosage strength of 800 mg/26.6 mg, following an approval from the Food and Drug Administration.
Ibuprofen and famotidine tablets is the generic of Horizon Medicines’ Duexis tablets, 800 mg/26.6 mg. Is is indicatead for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications.
This is the first FDA generic approval of Duexis tablets, 800 mg/26.6 mg. The launch is a subject of ongoing litigation.