US FDA approves Perrigo’s generic version of Valeant’s BenzaClin Gel

The US Food and Drug Administration (FDA) has approved Perrigo’s generic version of Valeant Pharmaceuticals’ BenzaClin Topical Gel.

The commercial launch will start immediately. The FDA concluded that Perrigo’s product is therapeutically equivalent to BenzaClin Gel 1%/5%.

Perrigo said it can be substituted with the full expectation that it will have the same clinical effect and safety profile as BenzaClin Gel 1%/5% when used under the conditions mentioned in the label.

BenzaClin Topical Gel (clindamycin phosphate 1% and benzoyl peroxide 5%) is indicated for the topical treatment of acne vulgaris.

Combined US sales of the branded and generic products for the 12-month period ending July were $231m.

Perrigo chairman, president and CEO Joseph Papa said: "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."

BenzaClin Topical Gel can be stored at room temperature up to 25°C for three months. It has a combination of benzoyl peroxide and clindamycin, which is an antibiotic that avoids bacteria from growing on the skin.

It should not be used if the patient is allergic to benzoyl peroxide or clindamycin. It could result in serious side effects.