Delayed-release diclofenac (Voltaren®) was approved by the FDA in July 1988 for the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and came off patent in 1996. Diclofenac potassium (Cataflam®) was approved January 1994 for treatment of pain or dysmenorrhea. A 3% topical gel (Solaraze™) was FDA-approved for the treatment of actinic keratosis in October 2000. A topical dosage form (Hyanalgese-D®) is under review by the FDA for the treatment of chronic pain associated with osteoarthritis; another product (Pennsaid® lotion) is approved in Europe for this use.

Additionally, diclofenac is marketed in several dosage forms. The rapid-release form of the potassium salt, Cataflam®, is indicated for treating pain and dysmenorrhea. Voltaren® is a delayed-release oral dosage form of the sodium salt of diclofenac. Ophthalmic diclofenac sodium is used to treat ocular inflammation after cataract extraction.

NOTE: In the United Kingdom and the United States, diclofenac may be supplied as either the sodium or potassium salt, while in some other countries only as the potassium salt. Over the counter (OTC) use is approved in some countries for minor aches and pains and fever associated with common infections.

 

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