10 New Drugs for Primary Care: Q1 2019
Highlights:  The first liquid solution of colchicine for prophylaxis of gout, the first generic version of Advair Diskus,® and 8 more new and approved drugs. (Source: ConsultantLive)
Source: ConsultantLive - April 11, 2019 Category: Internal Medicine Authors: Sydney Jennings Tags: ADHD Asthma COPD Depression Gout Headache and Migraine HIV AIDS Source Type: news

Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 21, 2019 Category: Drugs & Pharmacology Source Type: news

Mylan Launches Advair Generic at One-Third Price Mylan Launches Advair Generic at One-Third Price
Mylan NV on Tuesday priced its generic version of GlaxoSmithKline's blockbuster asthma treatment Advair 70 percent lower than the branded medicine.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - February 15, 2019 Category: Allergy & Immunology Tags: Pulmonary Medicine News Source Type: news

Touting pricetag, Mylan launches Advair generic
Mylan (NSDQ:MYL) today announced the launch of its Wixela Inhub product, a generic for GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus device, for people with asthma or chronic obstructive pulmonary disease. The company touted that its device’s list price is 70% less than Advair Diskus and 67% less than GSK’s generic. Get the full story at our sister site, Drug Delivery Business News. The post Touting pricetag, Mylan launches Advair generic appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 12, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat GlaxoSmithKline plc Mylan Source Type: news

Mylan's Advair generic starts at one-third price
Mylan's generic version of GlaxoSmithKline ’s asthma treatment, the first generic to be launched, is priced 70 percent lower than the blockbuster version. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - February 12, 2019 Category: Pharmaceuticals Source Type: news

Mylan launches Advair generic at one-third price
Mylan NV on Tuesday priced its generic version of GlaxoSmithKline's blockbuster asthma treatment Advair 70 percent lower than the branded medicine. (Source: Reuters: Health)
Source: Reuters: Health - February 12, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Walmsley’s GSK strategy revamp helps lift earnings
Drugmaker warns 2019 earnings likely to be hit by generic rival to Advair (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - February 6, 2019 Category: Pharmaceuticals Source Type: news

GSK strategy revamp and shingles drug help lift earnings
UK drugmaker warns 2019 earnings likely to be hit by generic rival to Advair asthma drug (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - February 6, 2019 Category: Pharmaceuticals Source Type: news

First Generic Version of Advair Diskus Approved for Asthma, COPD
Title: First Generic Version of Advair Diskus Approved for Asthma, COPDCategory: Health NewsCreated: 1/31/2019 12:00:00 AMLast Editorial Review: 2/1/2019 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - February 1, 2019 Category: Respiratory Medicine Source Type: news

FDA approves generic version of Advair Diskus for asthma, COPD
The U.S. Food and Drug Administration today approved the first generic form of the popular asthma inhaler Advair Diskus, according to the agency. (Source: Health News - UPI.com)
Source: Health News - UPI.com - January 31, 2019 Category: Consumer Health News Source Type: news

FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus
HERTFORDSHIRE, England and PITTSBURGH, Jan. 31, 2019 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced the U.S. Food and Drug Administration (FDA) approval of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 31, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves First Generic Version of Advair for Asthma, COPD
THURSDAY, Jan. 31, 2019 -- The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration. The medication can now be used to treat children... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 31, 2019 Category: Pharmaceuticals Source Type: news

Mylan wins race for generic Advair approval
FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application. Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than recovered by noon today, reaching $39.23. Get the full story on our sister site, Drug Delivery Business. The post Mylan wins race for generic Advair ap...
Source: Mass Device - January 31, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Drug-Device Combinations Food & Drug Administration (FDA) Respiratory GlaxoSmithKline plc Mylan Novartis Source Type: news

Morning Break: Generic Advair; Polar Vortex Deaths; Valsartan Gouging
(MedPage Today) -- Health news and commentary from around the Web gathered by the MedPage Today staff (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - January 31, 2019 Category: Pediatrics Source Type: news

First Generic Version of Advair Diskus Approved for Asthma, COPD
THURSDAY, Jan. 31, 2019 -- The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration. It can now be used to treat children aged 4 or... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 31, 2019 Category: General Medicine Source Type: news

Generic Version of Popular Asthma Inhaler, Advair Diskus, Wins FDA Approval
THURSDAY, Jan. 31, 2019 -- The first generic version of the widely used Advair Diskus inhaler for asthma and chronic obstructive pulmonary disease (COPD) has won U.S. Food and Drug Administration approval. This approval " is part of our longstanding... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 31, 2019 Category: General Medicine Source Type: news

FDA approves first generic Advair Diskus
The U.S. Food and Drug Administration approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (Source: World Pharma News)
Source: World Pharma News - January 31, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA OKs 1st generic version of popular Advair asthma inhaler
First generic version of popular Advair asthma inhaler approved by US regulators (Source: ABC News: Health)
Source: ABC News: Health - January 31, 2019 Category: Consumer Health News Tags: Health Source Type: news

FDA Approves First Generic Advair Diskus
January 30, 2019 -- The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 30, 2019 Category: Pharmaceuticals Source Type: news

FDA Approves First Generic of Advair Diskus FDA Approves First Generic of Advair Diskus
The Mylan generic comes in three strengths and is indicated for twice-daily treatment of asthma in patients as young as age 4 and for adults with COPD.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 30, 2019 Category: Consumer Health News Tags: Pulmonary Medicine News Alert Source Type: news

FDA approves Mylan's generic of Advair asthma treatment
The U.S. Food and Drug Administration (FDA) approved Mylan NV's generic version of GlaxoSmithKline-developed blockbuster asthma treatment Advair, driving shares of Mylan 7 percent higher on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - January 30, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first generic Advair Diskus
FDA approved the first generic of Advair Diskus for treatment of asthma and maintenance treatment of airflow obstruction and reducing exacerbations with COPD. (Source: Food and Drug Administration)
Source: Food and Drug Administration - January 30, 2019 Category: American Health Source Type: news

GSK’s shingles vaccine helps it shrug off Advair fears
UK drugmaker tightens full-year guidance towards upper end of expectations (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - October 31, 2018 Category: Pharmaceuticals Source Type: news

Glenmark inks licensing pact for generic Tiotropium Bromide dry powder inhaler in Western Europe
This is the second inhalation product in-licensed by Glenmark for the European market after Fluticasone/Salmeterol dry powder inhaler, the company said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 29, 2018 Category: Pharmaceuticals Source Type: news

FDA rejects Mylan ’s generic Advair again
Mylan announced that the FDA will not approve its Abbreviated New Drug Application for the generic version of GlaxoSmithKline's asthma drug, Advair Diskus, due to “minor deficiencies” in the application. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 15, 2018 Category: Pharmaceuticals Source Type: news

FDA Finds Deficiencies in Mylan's Generic Advair FDA Finds Deficiencies in Mylan's Generic Advair
Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug Advair for the second time, as they found"minor deficiencies" in the treatment.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 14, 2018 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

FDA rejects Mylan ’ s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects to wait until it receives the full notice on June 27 to determine how the rejection will impact its 2018 financial outlook. Get the full story at our sister site, Drug Delivery Business ...
Source: Mass Device - June 14, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Mylan Novartis Source Type: news

FDA finds deficiencies in Mylan's generic Advair; shares fall
(Reuters) - Mylan NV said on Wednesday that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug Advair, citing "minor deficiencies" with the drug. (Source: Reuters: Health)
Source: Reuters: Health - June 13, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA finds deficiencies in Mylan's generic Advair
(Reuters) - U.S. drugmaker Mylan NV said on Wednesday that U.S. health regulators could not approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug, Advair, and cited "minor deficiencies" with the copycat version. (Source: Reuters: Health)
Source: Reuters: Health - June 13, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bill would limit patient access to cheaper drugs
More than 25 million Americans suffer from asthma. The condition is well-known for restricting a patient ’s airway, making it difficult to breathe and often causing coughing and wheezing. In addition to putting the squeeze on a person’s lungs, asthma is also putting pressure on patients’ wallets, as the cost of inhalers has risen to about $5,000 a year. Doctors and patients were recently elated when a popular asthma medication went generic. Fluticasone/salmeterol is the first-ever generic asthma… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 16, 2018 Category: American Health Authors: Dr. John D. Bennett Source Type: news

Stronger pound weighs on GlaxoSmithKline revenues
UK drugmaker shares fall as it points to steeper decline in Advair sales (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - April 25, 2018 Category: Pharmaceuticals Source Type: news

GSK wins new reprieve as Hikma's generic Advair delayed again
(Reuters) - GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug. (Source: Reuters: Health)
Source: Reuters: Health - March 12, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Hikma plans new clinical study over generic Advair
(Reuters) - Hikma Pharmaceuticals Plc said on Monday it plans a new clinical study on its generic version of GlaxoSmithKline's popular lung drug Advair, as it looks to resolve an ongoing dispute with the Food and Drug Administration over plans to launch the drug in the U.S. (Source: Reuters: Health)
Source: Reuters: Health - March 12, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

GlaxoSmithKline Sees Light at End of Advair Tunnel GlaxoSmithKline Sees Light at End of Advair Tunnel
GlaxoSmithKline sees growth strengthening over the next few years as the drugmaker weathers increased competition in its core respiratory and HIV businesses that could cause earnings to dip this year.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 8, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

FDA rejects Novartis ’ Advair generic, leaving GSK without rival
GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. Get the full story at our sister site, Drug Delivery Business News. The post FDA rejects Novartis’ Advair generic, leaving GSK without rival appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Novartis sandoz Source Type: news

Drugmaker GSK wins fresh Advair reprieve as Novartis copy delayed
LONDON (Reuters) - GlaxoSmithKline has won another reprieve for its blockbuster Advair lung drug after U.S. regulators delayed approval of a generic copy from Novartis's Sandoz division. (Source: Reuters: Health)
Source: Reuters: Health - February 8, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

GlaxoSmithKline sees light at end of Advair tunnel
LONDON (Reuters) - GlaxoSmithKline sees growth strengthening over the next few years as the drugmaker weathers increased competition in its core respiratory and HIV businesses that could cause earnings to dip this year. (Source: Reuters: Health)
Source: Reuters: Health - February 7, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

AirDuo RespiClick Inhalation Powder (Fluticasone Propionate and Salmeterol) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 10, 2018 Category: Drugs & Pharmacology Source Type: news

Novartis' Ultibro ® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide®
Novartis today announced positive results from the FLASH** study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide® (salmeterol/fluticasone) 50/500 mcg to Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg[1]. The study met the primary endpoint demonstrating that switching patients to Ultibro Breezhaler resulted in significantly improved lung function (trough FEV1)[1]. (Source: World Pharma News)
Source: World Pharma News - November 27, 2017 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

A Case of Worsening Dyspnea and Cough
Bob is a 72-year-old male, with a 40-pack-year smoking history. He quit about 8 years ago, when severe COPD was diagnosed. Until last year, he had been stable on his regimen of Advair 250/50 and Spiriva Handihaler, other than an occasional “bronchitis,” usually treated with an antibiotic and/or steroids. Over the past year or so, however, he has noticed a marked turn for the worse. He no longer can walk up the steps in his house without stopping and gasping for breath. (Source: ConsultantLive)
Source: ConsultantLive - November 27, 2017 Category: Internal Medicine Authors: Jonathan Ilowite, MD Tags: Respiratory Diseases Source Type: news

Europe approves GlaxoSmithKline's new triple lung drug
LONDON (Reuters) - Europe has approved GlaxoSmithKline's new three-in-one inhaler for chronic lung disease, which the group hopes will help it keep its lead in respiratory medicine despite falling sales of older drug Advair. (Source: Reuters: Health)
Source: Reuters: Health - November 16, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Hikma, Vectura in dispute with FDA over generic Advair
LONDON (Reuters) - Hikma and its partner Vectura are in dispute with the Food and Drug Administration over their plans to launch a generic copy of GlaxoSmithKline's popular lung drug Advair in the U.S. market, delaying any eventual approval. (Source: Reuters: Health)
Source: Reuters: Health - November 9, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

GlaxoSmithKline breathes easier as U.S. approves triple lung drug
LONDON (Reuters) - U.S. regulators have approved GlaxoSmithKline's three-in-one inhaler for chronic lung disease, a key new product for the group as it strives to keep its lead in respiratory medicine despite falling sales of the older drug Advair. (Source: Reuters: Health)
Source: Reuters: Health - September 19, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

A Case of Worsening Dyspnea and Cough
Bob is a 72-year-old male, with a 40-pack-year smoking history. He quit about 8 years ago, when severe COPD was diagnosed. Until last year, he had been stable on his regimen of Advair 250/50 and Spiriva Handihaler, other than an occasional “bronchitis,” usually treated with an antibiotic and/or steroids. Over the past year or so, however, he has noticed a marked turn for the worse. He no longer can walk up the steps in his house without stopping and gasping for breath. (Source: ConsultantLive)
Source: ConsultantLive - August 22, 2017 Category: Internal Medicine Authors: Jonathan Ilowite, MD Tags: Respiratory Diseases Source Type: news

Mylan revises earnings guidance, defers product launches to 2018
Mylan NV on Wednesday said it is deferring all major U.S. launches from its full-year 2017 financial guidance to 2018, citing ongoing challenges and the uncertain U.S. regulatory environment. As a result, the pharmaceutical giant expects to deliver total revenues ranging between $11.5 billion and $12.5 billion and adjusted earnigns per share between $4.30 and $4.70. The product launches include generic versions of Advair and Copaxone. Mylan (Nasdaq:MYL) included the announcement in its quarterly… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 9, 2017 Category: Pharmaceuticals Authors: Patty Tascarella Source Type: news

Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus
Novartis (NYSE:NVS) unit Sandoz said today that the FDA has accepted the abbreviated new drug application for its generic version of Advair Diskus. The fluticasone propionate/salmeterol device is designed to treat asthma in patients ages 4 and older, as well as provide maintenance treatment of airflow obstruction and reduce exacerbations in patients with chronic obstructive pulmonary disease. Get the full story at our sister site, Drug Delivery Business News. The post Novartiz unit Sandoz seeks FDA nod for generic Advair Diskus appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 16, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Respiratory Wall Street Beat Amgen Novartis sandoz Source Type: news

US FDA issues CRL to Hikma ’s generic version of GSK’s Advair Diskus
Hikma Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) of its generic version of GlaxoSmithKline's Advair Diskus (fluticasone propionate and s … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 12, 2017 Category: Pharmaceuticals Source Type: news

GSK wins Advair reprieve as second generic falters
Hikma and Vectura shares fall as US FDA withholds approval for lung drug substitute (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - May 11, 2017 Category: Pharmaceuticals Source Type: news

GSK dodges bullet after another generic Advair competitor is denied
GlaxoSmithKline (NYSE:GSK) will not likely face generic competition to its lung drug Advair in the US this year. Yesterday, the FDA denied the application for a 2nd generic competitor. Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes on the heels of Mylan‘s (NSDQ:MYL) announcement in March that the federal watchdog delayed approval of its Advair generic. Thanks to these 2 rejections, industry analysts believe that the threat of generic competition has...
Source: Mass Device - May 11, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Hikma Pharmaceuticals PLC Mylan Source Type: news

GSK escapes Advair hit for now as second generic bid fails
LONDON (Reuters) - GlaxoSmithKline is likely to escape generic competition to its blockbuster lung drug Advair in the United States this year, after a second application for a cut-price equivalent form of the medicine was turned down by U.S. regulators. (Source: Reuters: Health)
Source: Reuters: Health - May 11, 2017 Category: Consumer Health News Tags: healthNews Source Type: news