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Unichem Labs gets USFDA nod for arthritis drug

Unichem Labs gets USFDA nod for arthritis drug

New Delhi : Drug firm Unichem Laboratories said it has received approval from the US health regulator for Piroxicam Capsules, used in treatment of osteoarthritis and rheumatoid arthritis, in the US market.

In a BSE filing, Unichem Laboratories said “it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Piroxicam Capsules USP 10 mg and 20 mg”.

The approved product is therapeutically equivalent to Feldene Capsules 10 mg and 20 mg of Pfizer Inc.

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA).

Unichem Laboratories said the product will be commercialised from its Goa plant.

“Active Pharmaceutical Ingredient will also be made in-house at Roha API Plant,” it added.

Shares of Unichem Laboratories were trading 1.49 per cent higher at Rs 290 on BSE.



Source: PTI
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