Perrigo Company has received final approval from the US Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Mycolog II cream (nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/gram). The company anticipates launching this product in the fourth quarter of 2017.
Mycolog II cream is indicated for the treatment of cutaneous candidiasis. Annual market sales for Mycolog II cream for the 12 months ended June 2017 were approximately $93 million.
Perrigo executive vice president and president Rx Pharmaceuticals John Wesolowski stated, "This final approval and anticipated launch exemplify Perrigo's ongoing commitment to developing quality, high value alternatives in important treatment categories. 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."