Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


HRT Class Labeling Should Not Cover Topical Estrogens, Pharmacia Says

Executive Summary

Topical hormone therapy drugs should be exempt from FDA's proposed estrogen class labeling incorporating safety information from the Women's Health Initiative study, Pharmacia maintained in comments submitted to the agency

You may also be interested in...

Pfizer/Pharmacia Clears FTC: Viagra Patent Strategy, HRT Safety Are Factors

Pfizer's patent defense strategy for Viagra is one reason the Federal Trade Commission is requiring the divestiture of Phase II erectile dysfunction disorder agents as a condition of the Pfizer/Pharmacia merger

Hormone Therapy Class Labeling Uses Wyeth Template; Appeals Due By March

Sponsors of hormone replacement therapies have two months to pull together data to justify exemptions to FDA's proposed class labeling incorporating risk information from the Women's Health Initiative

FDA Hormone Therapy Risk Management Options Include Narrower Indication

FDA is considering limiting hormone therapy indications to patients with more severe menopausal symptoms or those at a high risk for osteoporosis, Center for Drug Evaluation & Research Director Janet Woodcock, MD, said Oct. 24

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts