Alkem Laboratories Ltd. has announced the launch of Ibuprofen and Famotidine Tablets (800 mg/26.6 mg) in the United States, following an approval from the United States Food and Drug Administration (US FDA).

Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg.

This is the first generic approval of Duexis Tablets, 800 mg/26.6 mg by the US FDA. The launch is a subject of ongoing litigation.

Established in 1973, Alkem Laboratories Ltd. is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and International markets.