Mon Jun 25, 2012 2:52am EDT
LONDON, June 25 - U.S. regulators have ruled against Shire in a battle over generic copies of its hyperactivity drug Adderall XR, approving a cut-price version of the medicine from Watson Pharmaceuticals' Actavis unit.
Until now there have only been two authorised generic forms of Adderall XR, both supplied by Shire, and the arrival of the new competitor from Watson, despite an appeal against the move by Shire, will increase pricing pressure.
Analysts at Jefferies said the Food and Drug Administration's approval of the first abbreviated new drug application had been anticipated, but the move had come sooner than expected, which would likely hurt the stock.
Despite the setback, Shire said on Monday it continued to believe it would deliver good full-year 2012 earnings growth.
Adderall XR has been a mainstay of Shire's expanding ADHD (attention deficit hyperactivity disorder) drug business, although the company has newer drugs for the condition in Vyvanse and Intuniv that are both increasing U.S. market share.
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