Archive for August, 2008

Shire receives FDA nod for ADHD treatment

VivyanseShire Pharmaceuticals Inc. has received FDA approval for its Vyvanse drug for the treatment of adult attention deficit hyperactivity disorder (ADHD). In the clinical trials, Vyvanse (lisdexamfetamine dimesylate) significantly improved symptoms of inattention, hyperactivity and impulsivity in ADHD patients within one week of treatment. The trials also depicted that the drug’s efficacy at 30, 50 and 70-mg doses was significantly greater than placebo.

Second rotavirus vaccine gets FDA approval

RotarixThe FDA has approved a second oral rotavirus vaccine, called Rotarix, which is in liquid form and is given in a two-dose series to infants of 6 to 24 weeks of age. The rotavirus infection results in vomiting and diarrhea in children. The new vaccine provides protection against the G1, G3, G4, and G9 strains, which cause rotavirus gastroenteritis. The vaccine is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium.