Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Pfizer Gets FDA Response Letter for Lasofoxifene | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

Pfizer Gets FDA Response Letter for Lasofoxifene

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer received a complete response letter from the FDA asking for additional information on the company’s application for lasofoxifene, an investigational compound currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Pfizer will work with FDA to determine a course of action regarding the application.

Pfizer submitted the application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted in favor of the drug citing that the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel. On December 18, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency also issued a positive opinion of the drug, recommending marketing authorization.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters