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FDA approves Perrigo generic equivalents for dermatitis treatment
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The FDA has given final approval for Perrigo Co.’s abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, and fluocinolone acetonide topical oil, 0.01%, the company announced.
The products are the generic equivalent of Derma-Smoothe/FS Scalp Oil and Derma-Smoothe/FS Body Oil (Hill Dermaceuticals) and are indicated for topical treatment of atopic dermatitis in adults and topical treatment of moderate to severe atopic dermatitis in pediatric patients aged 3 months and older for up to 4 weeks, according to a press release. Perrigo anticipates shipping the products in September.
“This is another example of our Rx team’s commitment to launching difficult-to-manufacture topicals, lotions and foams,” Joseph C. Papa, Perrigo chairman and chief executive office, said in the release.