1 INDICATIONS AND USAGE Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

BROMFENAC is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

(1) .

6 ADVERSE REACTIONS The most commonly reported adverse reactions in 3 to 8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred.

( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.

at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most commonly reported adverse reactions following use of bromfenac ophthalmic solution following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and vision blurred.

These reactions were reported in 3 to 8% of patients.