Vyscoxa

NDA 211759, held by Carwin Pharm Assoc. Celecoxib.

As of Nov 13, 2026, NDA 211759 (Vyscoxa), held by Carwin Pharm Assoc, was first approved by FDA on Jul 29, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE VYSCOXA is indicated In adults for the management of the signs and symptoms of: VYSCOXA contains celecoxib, a nonsteroidal anti-inflammatory drug, and is indicated: In adults for

Osteoarthritis (OA)
Rheumatoid Arthritis (RA)
Ankylosing Spondylitis (AS) In pediatric patients two years and older f
Juvenile Rheumatoid Arthritis (JRA) Limitations of Use VYSCOXA must be administered on an empty stomach at least 2 hours before or 1 hour after food. Taking VYSCOXA with food results in plasma exposures of celecoxib up to 50% higher than intended. If patients cannot tolerate VYSCOXA in the fasted state, discontinue use of VYSCOXA ( 2.1, 5, 12 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jul 29, 2025	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Medication Guide

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vyscoxa10MG/ML · suspension;oral	Celecoxib	RxReference drug

Identifiers

Application: NDA 211759
Drugs@FDA: Overview at FDA
Company: Carwin Pharmaceutical Associates

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters