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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 11, 2017 Category: Pharmaceuticals Source Type: news

Teva launches AirDuo RespiClick, generic inhaled asthma therapies
Teva Pharmaceutical (NYSE:TEVA) said today that it launched the AirDuo RespiClick inhalation therapy and its authorized generic in the U.S. for asthma patients who are uncontrolled on an inhaled corticosteroid. AirDuo RespiClick and the generic are fixed-dose combination therapies contained fluticasone propionate and salmeterol – the same active ingredients as Advair. The therapies are delivered using Teva’s breath-activated RespiClick inhaler. Get the full story at our sister site, Drug Delivery Business News. The post Teva launches AirDuo RespiClick, generic inhaled asthma therapies appeared first on Mas...
Source: Mass Device - April 20, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Respiratory Wall Street Beat Teva Pharmaceuticals 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 MassD...
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

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

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

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

Advair Diskus (Fluticasone Propionate) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 23, 2016 Category: Drugs & Pharmacology Source Type: news

fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFA
Title: fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFACategory: MedicationsCreated: 1/22/2002 12:00:00 AMLast Editorial Review: 5/18/2016 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - May 18, 2016 Category: Drugs & Pharmacology Source Type: news

New Sandoz patient-centric inhaler now available to treat adults with COPD
Novel inhaler approved for adults with chronic obstructive pulmonary disease (COPD) (Source: Pharmacy Europe)
Source: Pharmacy Europe - November 24, 2015 Category: Drugs & Pharmacology Authors: Annabel De Coster Tags: *** Editor's Pick Practical therapeutics Respiratory Patient care AirFluSal copd fluticasone propionate Forspiro inhaler Latest News salmeterol Seretide Accuhaler treatment adherence Source Type: news

FDA cracks down on 1,000 illegal online medicine sellers
(Reuters) — The FDA said yesterday it had sent warning letters and seized potentially dangerous, unapproved medicines and medical devices from more than 1,050 websites globally. Inspectors from the FDA and other federal agencies screened and seized illegal drugs and medical devices received through international mail facilities in Chicago, Miami and New York, the FDA said in a statement. The health regulator said it sent warning letters to operators of nearly 400 websites and to 9 firms distributing unapproved medical devices online. The prescription drugs targeted included some purported to be the generic ...
Source: Mass Device - June 19, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

Adding a LAMA to Salmeterol/Fluticasone Improves COPD Lung FunctionAdding a LAMA to Salmeterol/Fluticasone Improves COPD Lung Function
Adding a once-a-day long-acting muscarinic antagonist (LAMA) to salmeterol/fluticasone propionate (SAL/FP) improves outcomes in chronic obstructive pulmonary disease (COPD), according to a report from Australia and New Zealand. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 8, 2015 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

How Medicare contributed to GSK's top line (Hint: Advair)
Medicare spent $2.26 billion on GlaxoSmithKline's (NYSE: GSK) asthma drug, Advair Diskus, in 2013, making it the second-costliest drug for the government payer in 2013. More than 1.5 million beneficiaries filed 6.6 million claims for the inhalable dry powder that comes in the plastic purple dispensing device. Large portions of the drug and the device are produced in Zebulon. For the first time, Medicare publicly released detailed information on the prescription drugs that health providers prescribed… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - May 1, 2015 Category: American Health Authors: Jason deBruyn Source Type: news

Lupin and Celon Pharma partner for generic version of GSK’s Advair Diskus
India-based drugmaker Lupin has signed an agreement with Polish biopharmaceutical firm Celon Pharma to develop a fluticasone / salmeterol dry powder inhaler (DPI). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 18, 2015 Category: Pharmaceuticals Source Type: news

Mylan to start Phase III trial of generic Advair Diskus, insulin analogue to Lantus
Global generic and specialty pharmaceuticals company Mylan is set to start a Phase III clinical trial of its generic version of GlaxoSmithKline's (GSK) Advair Diskus and its insulin analogue to Sanofi's Lantus. (Source: Drug Development Technology)
Source: Drug Development Technology - September 16, 2014 Category: Pharmaceuticals Source Type: news

GSK and Theravance reveal positive results from three Phase III trials in COPD
GlaxoSmithKline (GSK) and Theravance have reported positive results from three Phase III trials comparing Anoro Ellipta with Seretide Diskus and Advair Diskus in patients with chronic obstructive pulmonary disease (COPD). (Source: Drug Development Technology)
Source: Drug Development Technology - March 18, 2014 Category: Pharmaceuticals Source Type: news

GSK and Theravance Announce Positive Results From Studies Comparing ANORO(TM) ELLIPTA(TM) With SERETIDE(R) DISKUS(R) and ADVAIR(R) DISKUS(R) in Patients With COPD
LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA--(Healthcare Sales & Marketing Network) - GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from three phase III studies. Two studies comparin... BiopharmaceuticalsGlaxoSmithKline, Theravance, Anoro Ellipta, Advair Diskus, COPD (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 14, 2014 Category: Pharmaceuticals Source Type: news

fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFA
Title: fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFACategory: MedicationsCreated: 1/22/2002 7:43:00 PMLast Editorial Review: 7/15/2013 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - July 15, 2013 Category: Drugs & Pharmacology Source Type: news

fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFA
Title: fluticasone and salmeterol oral inhaler, Advair Diskus, Advair HFACategory: MedicationsCreated: 1/22/2002 7:43:00 PMLast Editorial Review: 7/15/2013 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - July 15, 2013 Category: Respiratory Medicine Source Type: news