Lupin 2023

Perrigo to release Mycolog II Cream generic

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DUBLIN, Ireland — Perrigo Co. plc has received approval from the Food and Drug Administration for nystatin and triamcinolone acetonide cream 100,000 units/gram and 1 mg/gram, an antifungal medication.

The company said Wednesday that its nystatin and triamcinolone acetonide product is a generic version of Mycolog II Cream from Bristol-Myers Squibb. The branded product was discontinued.

Perrigo expects to launch its Mycolog II Cream generic in the fourth quarter.

Indicated for the treatment of cutaneous candidiasis, the product is a combination medication that includes nystatin, to stop the growth of fungus, and triamcinolone, an anti-inflammatory corticosteroid to reduce swelling, itching and redness.

U.S. sales for Mycolog II Cream totaled approximately $93 million for the 12 months through June, Perrigo reported.

“This final approval and anticipated launch exemplify Perrigo’s ongoing commitment to developing quality, high-value alternatives in important treatment categories,” stated John Wesolowski, executive vice president and president of Rx Pharmaceuticals at Perrigo. “The Rx team continues to leverage our extended topicals strategy and development capabilities to deliver quality affordable health care products to customers, consumers and families around the world.”


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