Shire, New River shares surge on FDA approval

Shares of Shire and New River Pharmaceuticals were on the rise this morning as investors responded to the news that the FDA had approved NRP104, its next generation version of the popular ADHD drug Adderall. New River shares soared 51 percent in early trading as investors considered the impact of a milestone payment of up to $300 million and $100 million in annual bonuses if the drug breaks the billion-dollar revenue mark. Analysts were particularly bullish about the FDA's signal that no new studies would be needed to clear a market launch. Discussions about labeling requirements are in the works, but there's nothing in the approval that would indicate the developers can't make or beat their goal to launch NRP104 in the second quarter of next year.

- read the article on the approval from MarketWatch

PLUS: The FDA has approved Sepracor's Brovana for COPD. Report

ALSO: The FDA has approved Merck's Zolinza for non-Hodgkin's lymphoma in patients who have failed other therapies. Report

AND: The agency has approved J&J's Risperdal as a therapy for irritability in autistic children and adolescents. Report

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