AMAG Pharmaceuticals Announces Ferumoxytol Resubmission Designated Complete, Class 1 Response by the FDA (Centre Daily Times)
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date. AMAG is seeking ...

US FDA Approves 30-Minute Onset Of Action For Focalin(R) XR, Bringing Potential Benefits To ADHD Patients During Early ... (Medical News Today)
The US Food and Drug Administration (FDA) has approved a 30-minute onset of action for Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.

Statement By Merck & Co., Inc., In Response To The FDA's Update Regarding A Safety Review On Bisphosphonates Including ... (Medical News Today)
The FDA announced its update on the safety review of bisphosphonates, including FOSAMAX , that found no clear association between overall bisphosphonate exposure and the rate of serious or non serious atrial fibrillation. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation.