FDA bio Feb Mar.
03/31/2013
Johnson Johns
Posted On: 02/15/2013 5:24:00 PM
FDA bio Feb Mar.
03/31/2013 Johnson & Johnson JNJ Canagliflozin (NDA) (Trade name INVOKANA) FDA decision on INVOKANA for treatment of type 2 diabetes in adult patients 03/31/2013 United Therapeutics Corp UTHR Oral Treprostinil (NDA resubmission) FDA decision on oral Treprostinil for treatment of pulmonary arterial hypertension. 03/27/2013 AP Pharma Inc APPA.OB APF530 (NDA resubmission) FDA decision on APF530 for prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. 03/27/2013 Ariad Pharmaceuticals Inc ARIA Ponatinib (NDA) FDA decision on Ponatinib for patients with resistant or intolerant chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia 03/17/2013 Bristol-Myers Squibb Co. BMY Eliquis (NDA resubmission) FDA decision on Eliquis to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation FDA approved Eliquis on Dec.28, 2012 03/07/2013 GlaxoSmithKline PLC GSK , GSK.L BREO ELLIPTA (NDA) FDA panel to review BREO ELLIPTA for long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. 03/04/2013 DEPOMED INC DEPO Serada (NDA) FDA panel to review Serada for the treatment of menopausal hot flashes 03/01/2013 Zogenix, Inc. ZGNX Zohydro ER (NDA) FDA decision on Zohydro ER for treating moderate to severe chronic pain 02/26/2013 Immunogen Inc IMGN Trastuzumab emtansine (BLA) FDA decision on Trastuzumab emtansine for breast cancer 02/24/2013 Dynavax Technologies Corp DVAX Heplisav (BLA) FDA decision on Heplisav for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age
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