Lupin krijgt USFDA-knipoog voor generiek product

Lupin krijgt USFDA-knipoog voor generiek product

juni 3, 2020 0 Door admin

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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.

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 $14 million in the US.

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First Published on Jun 2, 2020 05:23 pm

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