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dDT

03/03/13 7:44 AM

#31684 RE: dDT #29119

March 2013 FDA plays

>>> Link back for February plays

03/01/2013 Zogenix, Inc. ZGNX Zohydro ER (NDA)
FDA decision on Zohydro ER for treating moderate to severe chronic pain
FDA decision to be delayed by several weeks



03/04/2013 DEPOMED INC DEPO Serada (NDA)
FDA panel to review Serada for the treatment of menopausal hot flashes




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.




03/17/2013 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




03/27/2013 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




03/31/2013 United Therapeutics Corp UTHR Oral Treprostinil (NDA resubmission)
FDA decision on oral Treprostinil for treatment of pulmonary arterial hypertension.




03/31/2013 Johnson & Johnson JNJ Canagliflozin (NDA) (Trade name INVOKANA)
FDA decision on INVOKANA for treatment of type 2 diabetes in adult patients