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Unichem Laboratories gets USFDA’s approval for Piroxicam Capsules

Unichem Laboratories has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Piroxicam Capsules USP 10mg & 20mg, which are therapeutically equivalent to Feldene Capsules 10mg & 20mg of Pfizer, Inc.

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) indicated for relief of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA). For the relief of rheumatoid arthritis and osteoarthritis, the dosage is 20 mg given orally once daily. If desired, the daily dose may be divided. Usually lowest effective dosage for the shortest duration, consistent with individual patient treatment goals is recommended.

The product will be commercialized from Unichem’s Goa plant. Active Pharmaceutical Ingredient (API) will also be made in house at Roha API Plant.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives.

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