|
|
Article: FDA warns companies to stop marketing unapproved ophthalmic drug products and products containing papain.(FDA Update: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.)
- Article from:
- Pharmaceutical Processing
- Article date:
- October 1, 2008
CopyrightCOPYRIGHT 2008 Advantage Business Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
The FDA has announced that companies marketing unaproved ophthalmic balanced salt Solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.
Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market ...