Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

FDA Approves Lower Dose Formulation of ANGELIQ Tablets

By Pharmaceutical Processing | March 1, 2012

Bayer HealthCare Pharmaceuticals Inc. has announced that the FDA has approved a lower dose formulation of ANGELIQ (drospirenone and estradiol) tablets to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25 mg drospirenone (drsp)/0.5 mg estradiol (E2)and will be available in the U.S. by prescription shortly.

The previously approved prescription formulation of ANGELIQ contains 0.5 mg drsp/1 mg E2 and is indicated for the treatment of moderate to severe vasomotor symptoms and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause in women who have a uterus.

“We are pleased by the approval of this important new lower dose option for menopausal women,” said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “The availability of the new lower dose of ANGELIQ supports current guidelines which recommend that treatment with hormone therapy should aim to use the lowest effective dose.” An estimated 6,000 women in the U.S. reach menopause every day,1 and hormone therapy (HT) remains an important therapeutic option for menopausal women to discuss with their healthcare provider.

  

 

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. 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 | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE