Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., April 22, 2010 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New [...]

Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations

INDIANAPOLIS, March 17, 2010 - Eli Lilly and Company (NYSE: LLY) today issued a statement and details regarding the stolen company products from its distribution operations in Enfield, Connecticut on Sunday, March 14.
Lilly is working with the U.S. Food and Drug Administration’s Office of Criminal Investigations (FDA), and other law enforcement officials, to recover cases of [...]

U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza™ (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults

PRINCETON, N.J. & WILMINGTON, Del. – Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a [...]

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 [...]