Perrigo announces FDA final approvals for generic equivalents to Derma-Smoothe/FS scalp, body oils
ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.
Derma-Smoothe/FS Scalp Oil (fluocinolone acetonide scalp oil, 0.01%) and Derma-Smoothe/FS Body Oil (fluocinolone acetonide topical oil, 0.01%) are indicated for the topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks. Both products have combined annual sales of approximately $25 million, as measured by Symphony Health Solutions.
Perrigo’s chairman, president and CEO Joseph C. Papa stated, "This is another example of our Rx team’s commitment to launching difficult to manufacture topicals, lotions and foams. We are excited to begin shipments of these products and are dedicated to making quality health care more affordable for all consumers around the globe."
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Co. has grown to become a leading global provider of quality, affordable healthcare products, the company stated. Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients.
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