TheraRadar
Data updated: Jul 17, 2026

PIROXICAM · MICRO LABS

Generic · see FELDENE
Immunology Approved 1982-04-06

PIROXICAM is FDA-approved to treat 2 conditions (same as FELDENE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
20
Indications
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1982-04-06
Routes
ORAL
Dosage Forms
CAPSULE

Companies

MICRO LABS FLAMINGO PHARMS UNICHEM LABS LTD BRECKENRIDGE Hikma STRIDES PHARMA SCS IVAX SUB TEVA PHARMS Teva EGIS CYCLE ZYDUS LIFESCIENCES WATSON LABS INC PHARMOBEDIENT SOLIS PHARMS Sun Pharma Viatris
Active Ingredient: PIROXICAM

PIROXICAM Approval History

1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
213 FDA actions from 1992 to 2026
Jun 2026 SUPPL
Label · Labeling
Mar 2026 SUPPL
Label · Labeling
Sep 2025 SUPPL
Label · Labeling

What PIROXICAM Treats

2 indications

PIROXICAM is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as FELDENE (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT06727734 UW 24-054 Ph 3 recruiting Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
NCT06404177 PiDex Dexketoprofene-Piroxicam Ph 3 recruiting Enantyum® IV Versus Piroxen® IM in Emergency Pain Management
NCT02304783 ONSAIP-RC Oral NSAI in RC Ph 3 completed Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics
NCT05722782 NAP-RC NAP in RC Ph 2 recruiting Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
NCT05488925 BDC/ERB/2021/016 Ph 4 completed Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.
NCT02450487 results posted 20657913.7.0000.5417 CAAE Ph 4 completed Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
NCT02253446 MDhayri2014 Ph 4 completed A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
NCT00670475 1/86010 Ph 2 completed Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PIROXICAM FDA Label Details

Indications & Usage

PIROXICAM is FDA-approved to treat 2 conditions — same approved indications as FELDENE.

Looking for the branded version?

FELDENE

Full clinical data, patents, trials, and competitive landscape for piroxicam.

See FELDENE

Data Sources

FDA Approval: ANDA206152 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.