Perrigo has received an AB therapeutic equivalent rating and final FDA approval for the generic version of Valeant Pharmaceutical International, Inc.'s BenzaClin® Topical Gel. The FDA concluded that Perrigo's product is therapeutically equivalent to BenzaClin® Gel 1%/5% and can be substituted with the full expectation that it will produce the same clinical effect and safety profile as BenzaClin® Gel 1%/5% when used under the conditions specified in the label. Shipments to customers will begin immediately.
BenzaClin® Topical Gel (clindamycin phosphate 1% and benzoyl peroxide 5%) is indicated for the topical treatment of acne vulgaris. Combined generic and branded sales for the twelve months ending July 2015 were $231 million.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This product approval and launch is an important addition to our growing Rx portfolio, through which we continue to provide affordable products to our customers around the world."