Sunovion Pharmaceuticals Inc.

285 articles with Sunovion Pharmaceuticals Inc.

• Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD

  4/3/2018

  LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) available for the treatment of COPD in the U.S.

• 

  Sunovion Submits NDA for Sublingual Parkinson's Treatment

  3/30/2018

  Sunovion Pharmaceuticals announced it submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease (PD).

• Sunovion Submits New Drug Application to the FDA for Apomorphine Sublingual Film (APL-130277) for the Treatment of OFF Episodes Associated with Parkinson’s Disease

  3/30/2018

  Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy versus placebo for the on-demand treatment of OFF episodes associated with Parkinson’s disease.

• 

  FDA Grants Sunovion’s Latuda Expanded Approval for Bipolar Depression in Pediatric Patients

  3/6/2018

  There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.

• Sunovion Receives FDA Approval of Supplemental New Drug Application (sNDA) for Use of Latuda® (lurasidone HCl) in the Treatment of Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)

  3/6/2018

  Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda® (lurasidone HCI) to include the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric patients (10 to 17 years of age).

• 

  Sunovion's Parkinson's Drug Succeeds in Late-Stage Trial

  1/30/2018

  The drug met its primary and key secondary endpoints, and the medicine was also generally well-tolerated by study participants.

• Magnair an eFlow Closed System Nebulizer Together With Sunovion's Lonhala is the First eFlow Technology Based Product to Receive FDA Approval to Treat COPD

  12/7/2017

  The drug//device combination product received FDA approval on December 5th, 2017 under a NDA.

• Sunovion Snags FDA OK for Lonhala Magnair Inhalation Solution to Treat COPD

  12/6/2017

  Sunovion expects LONHALA MAGNAIR to be available in U.S. pharmacies in early 2018.

• 

  Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Trea...

  11/10/2017

  The NDA submission is supported by multiple placebo-controlled safety and efficacy studies, as well as two long-term studies that assessed the safety of dasotraline in people with ADHD for up to one year.

• Sunovion Presents New Phase 3 Study Analyses Supporting Safety and Efficacy of SUN-101/eFlow (Glycopyrrolate) for the Treatment of COPD

  11/1/2017

  Sunovion Pharmaceuticals today presented new secondary analyses of safety and efficacy data from the Phase 3 GOLDEN clinical study program for SUN-101/eFlow (glycopyrrolate) at the American College of Chest Physicians (CHEST) Annual Meeting 2017 held October 28-November 1, 2017, in Toronto, Canada.

• Sunovion Presents Data From Phase III Studies of Latuda (Lurasidone HCl) in Children and Adolescents With Bipolar Depression

  10/30/2017

  The results showed that six weeks of treatment with LATUDA was associated with statistically significant and clinically meaningful improvement in a wide range of depressive symptoms compared to placebo.

• Sunovion Announces Seebri Neohaler (glycopyrrolate) Inhalation Powder is Now Available in the United States

  10/20/2017

  Sunovion Pharmaceuticals announced that Seebri Neohaler (glycopyrrolate) Inhalation Powder, 15.6 mcg twice daily, is now available at pharmacies in the United States.

• Sunovion’s Aptiom (Eslicarbazepine Acetate) Receives FDA Approval For Expanded Indication To Treat Partial-Onset Seizures In Children And Adolescents 4 Years Of Age And Older

  9/15/2017

• Sunovion Submits New Drug Application For Dasotraline To The FDA For The Treatment Of Patients With ADHD

  8/31/2017

• Sunovion’s Latuda (Lurasidone HCI) Receives Health Canada Approval To Treat Adolescents With Schizophrenia

  7/21/2017

• Sunovion Expands Commitment To Building Stronger Communities Through Partnerships With The Red Sox Foundation, United Way Of Tri-County And Bergen Volunteer Center

  7/18/2017

• Sunovion Enters Agreement To Divest Asthma And Allergy Products To Covis Pharma

  7/13/2017

• Sunovion Announces FDA Acceptance For Review Of Supplemental New Drug Application For Latuda (Lurasidone HCI) For The Treatment Of Bipolar Depression In Children And Adolescents

  6/30/2017

• Sunovion Announces FDA Acceptance For Review Of New Drug Application Resubmission For SUN-101/Eflow (Glycopyrrolate) For The Treatment Of Chronic Obstructive Pulmonary Disease (COPD)

  6/30/2017

• PsychoGenics Achieves A Milestone In Drug Discovery Collaboration With Sunovion

  6/13/2017