FDA Declines to Approve Mylan's Generic Of GSK's Advair for Now FDA Declines to Approve Mylan's Generic Of GSK's Advair for Now
Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc ' s blockbuster Advair asthma treatment, but provided no details of the agency ' s concerns or how long the product might be delayed.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - March 31, 2017 Category: Allergy & Immunology Tags: Pulmonary Medicine News Source Type: news
GSK's new CEO gets short-term win from generic Advair delay
LONDON (Reuters) - GlaxoSmithKline's new CEO Emma Walmsley, who takes over on April 1, has won a short-term reprieve from the threat of generic Advair with a delay in U.S. approval for Mylan's copy of the blockbuster lung inhaler. (Source: Reuters: Health)
Source: Reuters: Health - March 30, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA declines to approve Mylan's generic of GSK's Advair for now
(Reuters) - Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc's blockbuster Advair asthma treatment, but provided no details of the agency's concerns or how long the product might be delayed. (Source: Reuters: Health)
Source: Reuters: Health - March 29, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
Mylan shares down -3% after FDA rejects Advair generic
Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus.
The Canonsburg, Penn.-based company said it is “in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA’s feedback with the agency.”
Get the full story at our sister site, Drug Delivery Business News.
The post Mylan shares down -3% after FDA rejects Advair generic appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 29, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Clearance Respiratory Wall Street Beat GlaxoSmithKline plc Mylan Source Type: news
FDA, Mylan silence on generic Advair may be good news for GSK
LONDON (Reuters) - A deadline for U.S. regulators to give a verdict on a generic copy of GlaxoSmithKline's blockbuster inhaled lung drug Advair has passed with no sign of approval, sparking speculation that a threat to GSK profits might be delayed. (Source: Reuters: Health)
Source: Reuters: Health - March 29, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
AirDuo RespiClick Inhalation Powder (Fluticasone Propionate and Salmeterol) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 8, 2017 Category: Drugs & Pharmacology Source Type: news
As Teva Wins U.S. Approval for GSK Advair Copy, Main Fight Yet to Come As Teva Wins U.S. Approval for GSK Advair Copy, Main Fight Yet to Come
Israel ' s Teva Pharmaceutical Industries has won U.S. approval to market a copy of GlaxoSmithKline ' s best-selling Advair inhaler, although the real battle is still to come.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - January 31, 2017 Category: Allergy & Immunology Tags: Pulmonary Medicine News Alert Source Type: news
Teva Announces FDA Approval of AirDuo RespiClick (fluticasone propionate and salmeterol) for Maintenance Treatment of Asthma
JERUSALEM--(BUSINESS WIRE) January 30, 2017 --Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved AirDuo RespiClick (fluticasone propionate and salmeterol... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 30, 2017 Category: Drugs & Pharmacology Source Type: news
As Teva wins U.S. approval for GSK Advair copy, main fight yet to come
LONDON (Reuters) - Israel's Teva Pharmaceutical Industries has won U.S. approval to market a copy of GlaxoSmithKline's best-selling Advair inhaler, although the real battle is still to come. (Source: Reuters: Health)
Source: Reuters: Health - January 30, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
Advair HFA (Fluticasone Propionate and Salmeterol) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 22, 2016 Category: Drugs & Pharmacology Source Type: news
Advair Diskus, Advair HFA (fluticasone and salmeterol oral inhaler)
Title: Advair Diskus, Advair HFA (fluticasone and salmeterol oral inhaler)Category: MedicationsCreated: 1/22/2002 12:00:00 AMLast Editorial Review: 11/7/2016 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - November 7, 2016 Category: Respiratory Medicine Source Type: news
AstraZeneca, Bespak ink deal for metered-dose inhaler
AstraZeneca (NYSE:AZN) said last week that it inked a multi-year commercial supply deal with Consort Medical (LON:CSRT) subsidiary Bespak for its pressurized metered-dose inhaler technology.
Bespak will supply inhaler valves and actuators for use with AstraZeneca’s inhaled aerosol treatment for chronic obstructive pulmonary disease.
AstraZeneca won FDA approval in April for the aerosol, Bevespi Aerosphere (glycophrrolate and formoterol fumarate), indicated for long-term, maintenance therapy in patients with COPD.
“We are delighted to have successfully concluded this agreement with AstraZeneca,” Consort Medica...
Source: Mass Device - September 12, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Research & Development AstraZeneca plc Consort Medical Source Type: news
Advair Safety on Par With Monotherapy for Kids With Asthma (CME/CE)
(MedPage Today) -- But do all children benefit from combination therapy with a LABA? (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - August 31, 2016 Category: Allergy & Immunology Source Type: news
Novel LAMA/LABA Combo Shines for COPD (CME/CE)
(MedPage Today) -- Better than Advair for some measures in phase III trial (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - August 20, 2016 Category: Allergy & Immunology Source Type: news
Your inhaler ’ s watching you: drugmakers race for smart devices
(Reuters) – Makers of inhalers to treat asthma and chronic lung disease are racing to develop a new generation of smart devices with sensors to monitor if patients are using their puffers properly.
Linked wirelessly to the cloud, the gadgets are part of a medical “Internet of Things” that promises improved adherence, or correct use of the medication, and better health outcomes. They may also hold the key to company profits in an era of increasingly tough competition.
Drugmakers believe giving patients and doctors the ability to check inhaler use in this way could be a big help in proving the value of thei...
Source: Mass Device - July 20, 2016 Category: Medical Equipment Authors: MassDevice Tags: mHealth (Mobile Health) Patient Monitoring Respiratory AstraZeneca plc GlaxoSmithKline plc Novartis AG Qualcomm Source Type: news
