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Unichem Labs gets USFDA nod for arthritis drug – Hindu Business Line

April 17th, 2017 11:42 am

New Delhi, April 17:

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

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

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

(This article was published on April 17, 2017)

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Unichem Labs gets USFDA nod for arthritis drug - Hindu Business Line

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