Lupin gets USFDA approval for Meloxicam to treat osteoarthritis pain
Meloxicam Capsules, 5 mg and 10 mg, are indicated for the management of osteoarthritis (OA) pain
Mumbai, Baltimore: Drug maker Lupin Limited announced that it has received approval for its Meloxicam Capsules, 5 mg and 10 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Vivlodex® Capsules, 5 mg and 10 mg, of Zyla Life Sciences US, Inc.
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 the management of osteoarthritis (OA) pain.
Meloxicam Capsules (RLD: Vivlodex®) had annual sales of approximately USD 14 million in the U.S. (IQVIA MAT March 2020).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.