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Article: Marketing of unapproved drug products must stop - US FDA
- Article from:
- Reactions Weekly
- Article date:
- October 4, 2008
- Author:
CopyrightCopyright Wolters Kluwer Health Adis International Oct 4, 2008. Provided by ProQuest LLC. (Hide copyright information)
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The US FDA warns that the marketing of unapproved topical papain-containing products and unapproved ophthalmic balanced salt solution (BSS) must cease. "These unapproved products have put consumers health in jeopardy", said Dr Janet Woodcock, director for the FDA's Center for Drug Evaluation and Research.
No topical drug product containing papain has been approved by the FDA. Companies marketing any topical drug products containing papain must stop manufacturing them by 24 Nov 2008; similarly, those involved in shipping these products must stop doing so by 21 Jan 2009. The agency is acting after receiving reports of serious adverse events associated with use of papain-containing products, ...