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September 30, 2008
To Health Care Provider,
An Important message from Stratus Pharmaceuticals Inc
Dear Professionals:
On September 22, 2008, the FDA issued a notice regarding products containing topical papain. In this notice the FDA informs all manufacturers of products containing topical papain to stop manufacturing such products by November 24, 2008 and to stop shipping these products by January 21, 2009
Two of Stratus' products, Kovia ointment (papain/urea) and Ziox Ointment (papain/urea/clorophyllin are included in this action. Stratus Pharmaceuticals intends to comply with the directions of the FDA.
It is important to note that this notice does not represent a recall notice.
For the past eight years Stratus has manufactured these products and hundreds of thousands of patients have benefited from their efficacy and the cost containment.
Stratus is working diligently with the FDA to comply with the FDA requirements to bring these products to an approved status and are confident that we will have a positive resolution on this matter. Stratus will take all necessary steps and will not spare any expenses to comply with all FDA requirements and supply these reliable products that leave a void in the armamentarium of your practice if removed from the market.
That is our commitment to you.
We Sincerely appreciate your support for our products.
Best regards
Alberto Hoyo President
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