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17 Oct 2015

FDA Reject Pfizer’s Supplemental New Drug Application to Treat Psoriasis

U.S. health regulators have rejected Pfizer Inc.’s Xeljanz, or tofacitinib citrate supplemental new drug application to treat adult patients with moderate to severe chronic plaque psoriasis, the company said Wednesday.

Psoriasis is a skin disease that causes itchy or sore patches of skin.

The U.S. Food and Drug Administration asked Pfizer to submit additional information on Xeljanz, or tofacitinib citrate, such as further safety analyses for the proposed indication.

Xeljanz is approved to treat rheumatoid arthritis and is one of Pfizer’s top selling drugs. For the first six months of the year, Pfizer reported $224 million in sales for the pill, primarily in the U.S., compared with $120 million in the year-ago period.

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