FDA rejects tibolone as menopause treatment in US

Published: 5-Jun-2006

The US Food & Drug Administration (FDA) has decided not to approve tibolone as a menopause treatment in the US. The decision is a disappointment to Akzo Nobel which has been marketing the drug in countries outside the US for nearly 20 years.


The US Food & Drug Administration (FDA) has decided not to approve tibolone as a menopause treatment in the US. The decision is a disappointment to Akzo Nobel which has been marketing the drug in countries outside the US for nearly 20 years.

Akzo's human healthcare business unit Organon, which filed an amendment to the NDA with the FDA in December 2005, plans to withdraw the application for tibolone.

"Although Organon is disappointed with the FDA's response, we will continue to be committed to this proven brand," said Toon Wilderbeek, general manager of Organon and member of Akzo Nobel's Board of Management responsible for Pharma.

See more

You may also like

Medical Devices

Syensqo introduces medical-grade Amodel PPA for single-use, high-temperature medical devices

Read more
A new medical-grade Amodel PPA delivers high heat resistance, electrically insulative properties, and biocompatibility for advanced single-use medical instruments and assemblies

Trending Articles

  1. Continuous innovation: redefining the future of pharmaceutical manufacturing In an industry in which reliability is paramount and change can be slow, GEA has consistently proven that innovation and stability go hand in hand. Almost two decades ago, GEA introduced the first ConsiGma® continuous manufacturing (CM) system to the pharmaceutical market — a pioneering move that helped to reshape how oral solid dosage (OSD) forms are developed and produced
  2. Abselion launches AAVX and AAV9 Total Capsid Quantification Kits Ready-to-use solution for Amperia benchtop platform supports rapid, reliable quantification across a range of serotypes
  3. diaago and Peak Analysis & Automation partner to bring practical automation solutions to research laboratories Using diaago's customer-first approach with PAA’s decades of expertise in laboratory robotics, the collaboration promises to deliver solutions to streamline workflows, boost throughput and reduce bottlenecks
  4. Suncombe and Kindeva collaborate to deliver low-carbon inhalers to the NHS The partnership will develop next-generation pressurised metered-dose inhalers with low Global Warming Potential propellants, helping the NHS move closer to its Net Zero target
  5. Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision Partnership delivers compliance confidence, efficiency gains and reduced waste

Upcoming event

Enhancing probiotic stability through smarter formulation and packaging strategies

18 September 2025 | Virtual See all

You may also like

Medical Devices

Syensqo introduces medical-grade Amodel PPA for single-use, high-temperature medical devices

A new medical-grade Amodel PPA delivers high heat resistance, electrically insulative properties, and biocompatibility for advanced single-use medical instruments and assemblies
Manufacturing

Sapio Sciences introduces world’s first 3rd-generation ELN

Sapio ELaiN is an AI-powered lab notebook designed to act as a scientific collaborator
Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

New SOLAR CEMNEX analyser offers advanced compliance and connectivity features
Research & Development

Genoskin raises $8.7m in its first funding round to advance its ethical, human-based alternatives to animal testing

The financing will drive Genoskin’s next phase of growth, with a view to scaling up operations in both the US and France
You need to be a subscriber to read this article.
Click here to find out more.
Packaging

Cloud labelling and serialisation: the new frontline of traceability in drug delivery

As drug delivery evolves to accommodate a new wave of data-driven innovation, the need for traceability and compliance throughout the supply chain is paramount. Innovative cloud-based solutions enable pharmaceutical companies to navigate these demands with confidence
Manufacturing

Sharp boosts autoinjector and pen assembly line capability with $20m investment in Pennsylvania facility

The money will boost its autoinjector and pen assembly, labelling and packaging lines across various therapeutic areas at its facility in Macungie, meeting the rising demand for injectables
Manufacturing

L.B. Bohle to showcase machines for OSD, food and nutraceuticals at PACK EXPO 2025

Company to present advanced blending, particle sizing and coating technologies at Las Vegas event
Subscribe now