• 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

Lawsuit stalls approval of Merck’s insulin injection

July 20, 2017 By Sarah Faulkner

MerckMerck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection.

The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval.

The stay could last up to to 30 months, according to the Hatch-Waxman Act. If a court rules in favor of Merck before that period ends, the product can hit the market.

“The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” Dr. Sam Engel, associate VP of clinical research, for Merck’s diabetes, endocrinology & women’s health businesses, said in prepared remarks.

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: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Merck, Sanofi-Aventis

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