Impax Labs, Tolmar receive FDA approval for generic version of Solaraze
HAYWARD, Calif., and FORT COLLINS, Colo. — Impax Labs and Tolmar announced that the Food and Drug Administration has given final approval to Tolmar's generic version of Solaraze (diclofenac sodium) gel in the 3% strength.
Impax Labs entered into a Development, Supply and Distribution agreement with Tolmar on June 12 in which Tolmar granted Impax Labs an exclusive license to commercialize generic Solaraze in the United States. Under the terms of that agreement, Tolmar is responsible for product development and manufacturing, and Impax Labs is repsonsible for marketing and sales of the product.
Sales of Solaraze gel 3% in the United States were $78 million for the 12 months ended Sept. 2013.