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FDA Declines to OK Allergan Pill for Psoriasis

September 28, 2004|From Bloomberg News

The Food and Drug Administration rejected Allergan Inc.'s application for treating psoriasis with tazarotene capsules, the company said Monday.

Irvine-based Allergan, best known as the maker of wrinkle-reducing Botox, said regulators asked for a study that showed the drug was not inferior to other treatments for severe psoriasis. In addition, the FDA asked for a more comprehensive plan for making sure tazarotene, which can cause birth defects if taken by pregnant women, is not widely used for less serious conditions such as acne, and sought improvements to the capsules' manufacturing.

Allergan already sells gel and cream forms of tazarotene in the U.S. for treating psoriasis and acne. It planned to have a pill form on the market by next year with annual revenue in the range of $200 million.

"Obviously, that is not going to happen at this point," company spokeswoman Stephanie Fagan said.

Psoriasis is a noncontagious skin disorder characterized by reddish patches with silver-colored scales.

Shares of Allergan fell $2.25 to $75.64 on the New York Stock Exchange.

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