Pink Sheet is part of the Business Intelligence Division 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


Barr low-dose Cenestin "not approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Barr's 0.45 mg formulation of its plant-derived hormone therapy Cenestin receives "not approvable" letter, firm announces June 3. The 0.45 mg synthetic conjugated estrogens tablet is under review for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Cenestin is currently available in 0.3 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets, but the 0.3 mg dosage strength is indicated only for the treatment of vulvar and vaginal atrophy. The agency's decision follows recent approvals of low-dose formulations of Wyeth's Premarin and PremPro (1Pharmaceutical Approvals Monthly May 1, 2003, In Brief). Safety concerns from the Women's Health Initiative study have led to increased interest in lower dose hormone therapies. Barr plans to meet with FDA "as soon as possible"...

Related Content

Wyeth’s second low-dose HRT





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