Lupin receives US FDA approval for Meloxicam capsules

Pharma major Lupin announced that it has received approval for its Meloxicam Capsules, 5 mg and 10 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Vivlodex Capsules, 5 mg and 10 mg, of Zyla Life Sciences US. The product would be manufactured at Lupin’s Aurangabad facility, India, and is expected to be launched shortly.

Meloxicam Capsules, 5 mg and 10 mg, are indicated for management of osteoarthritis (OA) pain.

Meloxicam Capsules (RLD: Vivlodex®) had an annual sales of approximately USD 14 million in the U.S. (IQVIA MAT March 2020).