The FDA has approved Fragmin, a low molecular weight heparin, for the treatment of symptomatic venous thromboembolism to reduce the recurrence of VTE in pediatric patients 1 month of age and older.
When used as needed, the combination of budesonide-formoterol was found to be superior to albuterol for the prevention of asthma exacerbations in patients with mild asthma.
Par is recalling 1 lot of Mycophenolate Mofetil for Injection following the discovery of a glass fragment within a reconstituted vial.
A new PDUFA date for the treatment is now June 21, 2019; the FDA did not request additional studies from the Company.
Results from a phase 3 trial evaluating Trelegy Ellipta in patients with uncontrolled asthma showed that the single inhaler triple therapy provided a significant improvement in lung function.
The FDA has expanded the indication for Kalydeco to include treatment of cystic fibrosis in patients 6 months of age and older.
