SILVER SPRING, Md. — Perrigo has received Food and Drug Administration approval for its generic of Mycolog II cream (nystatin and triamcinolone acetonide cream, 100,000 units/g and 1 mg/g) cream, the company announced Wednesday.
“This final approval and anticipated launch exemplify Perrigo's ongoing commitment to developing quality, high value alternatives in important treatment categories.” Perrigo EVP and president Rx pharmaceuticals John Wesolowski said. “The Rx team continues to leverage our extended topicals strategy and development capabilities to deliver Quality Affordable Healthcare Products to customers, consumers and families around the world.”
The drug is indicated to treat cutaneous candidiasis. It had a U.S. market size of $93 million for the 12 months ended June 2017. The company said it anticipates a launch in the fourth quarter of 2017.