Impax Labs and Tolmar, Inc. announced that the FDA has granted final approval of Tolmar’s abbreviated New Drug Application (ANDA) for Diclofenac Sodium 3% Gel, the generic version of PharmaDerm’s Solaraze Gel.
Solaraze (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.
The mechanism of action of diclofenac sodium in the treatment of actinic keratoses is unknown.
Actinic keratoses are small, rough, raised areas found on skin that has been exposed to the sun for a long period of time. They are usually found on the face, scalp, back of the hands, chest, or places that are often in the sun. Some actinic keratoses may develop into a type of skin cancer.
For more information call (215) 558-4526 or visit ImpaxLabs.com.