Perrigo Company (PRGO) announced it has received final approval from the U.S. FDA 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.
Derma-Smoothe/FS Scalp Oil and Derma-Smoothe/FS Body Oil 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. Perrigo expects to begin shipments of both products next month.
by RTT Staff Writer
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