sNDA Archives - World Asthma Foundation

July 1, 2014

GSK and Theravance submit US sNDA for Breo Ellipta in asthma – The Pharma Letter

GSK and Theravance submit US sNDA for Breo Ellipta in asthma
The Pharma Letter
Today's filing is based on data generated from the comprehensive clinical development program for FF/VI in asthma. The clinical development program comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients …
Glaxo, Theravance File Asthma Drug Application with FDANASDAQ
Glaxo submits new drug application for asthma treatmentIFA Magazine
GSK and Theravance Announce Submission to US Regulatory Authorities for …MarketWatch
RTT News
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September 20, 2012

Acton Says FDA Oks SNDA For AEROSPAN Inhalation Aerosol For Asthma – RTT News

Acton Says FDA Oks SNDA For AEROSPAN Inhalation Aerosol For Asthma
RTT News
… has approved the sNDA (Supplemental New Drug Application) for AEROSPAN Inhalation Aerosol, a hydrofluoroalkane orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients …

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July 12, 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.