September 3, 2009 / 11:26 AM / 8 years ago

UPDATE 1-Shire wins U.S. approval for Intuniv drug

* FDA approves extended-release hyperactivity drug

* Intuniv to go on sale in November in U.S.

* Shire shares up 0.5 percent

(Adds details, background)

LONDON, Sept 3 (Reuters) - U.S. regulators approved Shire Plc’s (SHP.L) extended-release hyperactivity drug Intuniv and the product is expected to be available in U.S. pharmacies in November, the company said on Thursday.

Shire shares rose 0.5 percent by 1115 GMT, outperforming a 0.6 percent decline in line with the DJ Stoxx European healthcare sector .SXDP.

Intuniv will be the first selective alpha-2A receptor agonist for the treatment of attention deficit hyperactivity disorder (ADHD). It is designed to be given to children and adolescents aged 6 to 17 years.

Intuniv’s path to market was delayed in July when the Food and Drug Administration issued a so-called complete response letter, following lengthy labelling discussions. But Shire said at the time it still expected a launch before the end of 2009.

Intuniv, along with another already launched ADHD drug called Vyvanse, represents the future of Shire’s hyperactivity business as its former blockbuster Adderall XR faces generic competition.

The company, which is Britain’s third largest drugmaker, is also pinning its hopes on a new human genetic therapies division that makes medicines to treat a range of rare diseases. (Editing by David Holmes)

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