Unichem Laboratories Receives ANDA Approval for Piroxicam Capsules

Global Data Point

April 19, 2017

Unichem Laboratories has received 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 Unichemís Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant.

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