Unichem Laboratories receives ANDA approval from US FDA for piroxicam caps

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (US FDA) for piroxicam capsules USP 10mg and 20mg, which are therapeutically equivalent to Feldene Capsules 10mg and 20mg of Pfizer. Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) indicated for the 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 commercialised from Unichem’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Roha API Plant.