Teva Animal Health announced that Malaseb Shampoo, an antimicrobial, has returned to the market after an almost two-year sabbatical.
In July 2009, the Food and Drug Administration issued a consent decree after finding significant cGMP violations at the company’s St. Joseph, Mo., facilities during inspections between 2007 and 2009.
Under the terms of the consent decree, Teva Animal Health could not resume manufacturing or distribution of veterinary drugs until adequate methods, facilities and controls were established and an independent expert inspected the facilities and procedures and certifies cGMP compliance.
“We can’t thank veterinarians enough for their continued support during Malaseb’s absence,” said Dave Cunningham, president and CEO of Teva Animal Health. “The eagerness and excitement expressed for its return is humbling. We thank the veterinary community from the bottom of our hearts for backing Malaseb and the DVM Pharmaceuticals brand.”
Malaseb Shampoo, a medicated topical, contains miconazole nitrate and chlorhexidine gluconate antimicrobial formulation for use on dogs and horses. Miconazole nitrate is an antifungal agent with activity against gram-positive bacteria and fungi, including yeast and dermatophytes.
Chlorhexidine gluconate, an antiseptic, provides persistent activity against microorganisms, including gram positive and gram-negative bacteria and some species of yeast, according to the company.
The company says the shampoo is intended for use on dermatological conditions and contains a surfactant base to remove damaged lipids from the skin while simultaneously using conditioners to retain moisture within the skin and coat.
“Published data on the formulation and its effectiveness are what make Malaseb so special in the marketplace today,” says Ken Kwochka, DVM, Dipl. ACVD, Teva’s veterinary director of commercial services.
“Two percent miconazole nitrate with 2 percent chlorhexidine gluconate was the only topical formulation recommended for Malassezia dermatitis in an evidence-based systematic review.”
Malaseb Shampoo is available through licensed veterinarians and may be purchased through major veterinary distributors in the U.S. For more information on Malaseb click here.