Lupin gets USFDA nod for generic product

Drug maker Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant in Nagpur.
Drug maker Lupin

New Delhi, Jun 2 (PTI) Drug maker Lupin on Tuesday said it has received approval from the US health regulator to market Meloxicam capsules, used to treat osteoarthritis pain, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for meloxicam capsules in strength of 5 mg and 10 mg, Lupin Ltd said in a statement.

The Mumbai-based company’s product is the generic version of Zyla Life Sciences US, Inc’s Vivlodex capsules, it added.

“The product would be manufactured at company’s Aurangabad facility, and is expected to be launched shortly,” the drug maker said.

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

According to IQVIA MAT March 2020 data, Meloxicam capsules had annual sales of around USD 14 million in the US.


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