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 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 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
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
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
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 MassDevice. (Source: Mass Device)
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 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
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
