FDA Expands Use of Approved Breast Cancer Drug

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.
HER2 is a protein involved in normal cell growth. It is found on some types of cancer cells, including breast cancer cells. In [...]

FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal®XR™ (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures.  This is an expanded label, as Lamictal XR is approved for partial onset seizures (with or without secondary generalization) for patients [...]

FDA Authorizes Peramivir for H1N1

Washington, DC – In response to a request from the U.S. Centers for Disease Control and Prevention, The Food and Drug Administration has issued an emergency use authorization for the intravenous (IV) investigational antiviral drug Peramivir, to be used in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are [...]