• 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

TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms

December 29, 2017 By Sarah Faulkner

TherapeuticsMDTherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause.

The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule.

Shares in TherapeuticsMD fell earlier this month after the company announced that the FDA accepted its resubmitted application for TX-004HR, an applicator-free estradiol vaginal soft-gel capsule for the treatment of dyspareunia.

The company’s shares took a hit presumably because it revealed that its resubmitted application is a Class 2 response. A Class 1 response would have quickened the timeline for potential approval but as a Class 2 response, the FDA can take up to six months to make a decision.

TXMD shares were trading at $6.01 apiece in early morning activity today, up +1.4%.

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, Wall Street Beat, Women's Health Tagged With: TherapeuticsMD

IN CASE YOU MISSED IT

  • Dexcom updates CGM receiver recall that led to serious adverse events
  • Abbott reports momentum with Libre CGM business as new dual sensor will ‘accelerate’ growth
  • Johnson & Johnson wins FDA priority review for drug delivery system
  • Glucose monitoring company LifeScan files chapter 11 to reduce debt
  • Medtronic enrolls first patient in study for Onyx liquid embolic system

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