Tag: sNDA
-
GSK and Theravance submit US sNDA for Breo Ellipta in asthma – The Pharma Letter
The Pharma Letter GSK and Theravance submit US sNDA for Breo Ellipta in asthmaThe Pharma LetterToday'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…
-
Acton Says FDA Oks SNDA For AEROSPAN Inhalation Aerosol For Asthma – RTT News
Acton Says FDA Oks SNDA For AEROSPAN Inhalation Aerosol For AsthmaRTT 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 … View full post on asthma – Google News
-
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…