FDA reaffirms Shire exclusivity on attention-deficit-hyperactivity disorder drug
The FDA has given Shire PLC reaffirmation on a prior decision to give the attention-deficit-hyperactivity disorder drug Vyvanse five years of market exclusivity. The drug was first approved in 2007 for children between 6 and 12 years old and then again in 2008 for adults. It has competition-free sales until February 23, 2012. GlaxoSmithKline’s sales force is helping in the promotion of the drug in the US.



The FDA has approved UCB Corp’s 
Israel-based
The FDA has delayed the final approval of
DA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.
bmitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.