• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA rejects Mylan’s Advair generic in win for GSK

June 14, 2018 By Sarah Faulkner

MylanShares 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.

For now, GSK can breath a collective sigh of relief. The company’s product brings in $3 billion in annual sales for the company and a number of companies are looking to take a bite out of that market. But so far, all of GSK’s competitors have received setbacks from the FDA. For example, the U.S. regulatory agency denied Novartis’ application for an Advair generic in February this year.

In its 2017 earnings report, GSK said that if there is no generic competition for Advair this year, its earnings could jump by as much as 7%.

The pharma company’s Advair drug-device combination is designed for asthma patients ages 4 and older. The fluticasone propionate/salmeterol device also treats airflow obstruction and lessens exacerbations in patients with chronic obstructive pulmonary disorder.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Mylan, Novartis

IN CASE YOU MISSED IT

  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott
  • Study links Abbott CGM use to lower risk of hospitalizations due to heart complications

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS