Sunovion Pharmaceuticals Inc.
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285 articles with Sunovion Pharmaceuticals Inc.
Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD
LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) available for the treatment of COPD in the U.S.
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
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.
3/6/2018There 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)
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).
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
The drug//device combination product received FDA approval on December 5th, 2017 under a NDA.
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...
11/10/2017The 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
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
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
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
Sunovion Submits New Drug Application For Dasotraline To The FDA For The Treatment Of Patients With ADHD
Sunovion’s Latuda (Lurasidone HCI) Receives Health Canada Approval To Treat Adolescents With Schizophrenia
Sunovion Expands Commitment To Building Stronger Communities Through Partnerships With The Red Sox Foundation, United Way Of Tri-County And Bergen Volunteer Center
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
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)