Merz North America (Merz Aesthetics, Inc. and Merz Pharmaceuticals, LLC) has announced that, as of January 9, 2013, the court-ordered injunction has been lifted and patients and physicians now have access to a broader range of treatment options in aesthetic medicine, dermatology, and neurology.
“The violations that led to this injunction were directly attributable to the acts of several individuals, and were entirely incompatible with Merz’s culture. We accepted the injunction as a challenge to us to reinforce compliance training throughout the company and to re-imagine a company-wide compliance program. Last summer we directed all our efforts and resources toward the remediation process, and were pleased when the court agreed to a partial lift of the injunction in November 2012,” said Katrina Church, Vice President – Chief Compliance Officer of Merz, Inc. “We believe that compliance policies are an investment in our company’s future.”
Merz North America (Merz Aesthetics, Inc. and Merz Pharmaceuticals, LLC) is now permitted to sell and promote its entire portfolio of FDA-approved products, including XEOMIN® (incobotulinumtoxinA), BELOTERO BALANCE® Dermal Filler, and Radiesse® Volumizing Filler, in the U.S. with no restrictions imposed by the court order.
“Never at any point did the injunction question the quality of Merz’s products,” said Bill Humphries, President and Chief Executive Officer of Merz, Inc. “Although the injunction represented a challenge to our business activities, I am proud to announce that during those ten months, we continued to advance our core business, launching Naftin® (naftifine hydrochloride) 2% cream, filing a NDA with the FDA for Naftin® (naftifine hydrochloride) 2% gel, acquiring two novel prescription products (CUVPOSA® and Onmel™) and naming and staffing our Merz North American Leadership Team. Moving into 2013 our focus will be on sales and marketing execution in the marketplace, business development and licensing, and the organic expansion of our pipeline to better serve patients and physicians. We look forward to expanding our leadership role in dermatology within prescription antifungals, continuing our growth trajectory in movement disorders and commercialising our full suite of aesthetic products.”