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FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Date:1/25/2012

d well-controlled studies of Picato® gel in pregnant women. Picato® gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and effectiveness of Picato® gel for actinic keratosis in patients less than 18 years of age have not been established.

Please see full prescribing information available at www.leo-pharma.us/home/products/LEO-pharma-products.aspx.  

About LEO Pharma
LEO Pharma Inc. is a wholly owned subsidiary of LEO Pharma A/S. Founded in 1908, LEO Pharma A/S is an independent, research-based pharmaceutical company. LEO Pharma A/S develops, manufactures and markets pharmaceutical drugs in more than 100 countries globally. The company has its own sales forces in 61 countries and employs more than 4,600 employees worldwide. LEO Pharma A/S is headquartered in Denmark and is wholly owned by the LEO Foundation. For more information about LEO Pharma, visit www.leo-pharma.com.

[1] "What Are Actinic Keratoses?" ActinicKeratosesNet. American Academy of Dermatology. Updated October 19, 2005. Accessed December 1, 2011. http://www.skincarephysicians.com/actinickeratosesnet/whatare.html.

[2]  "Squamous Cell Carcinoma." Skincancer.org. The Skin Cancer Foundation. Accessed December 1, 2011. http://www.skincancer.org/squamous-cell-carcinoma.html.

[3] Picato® [prescribing information]. Parsippany, NJ: LEO Pharma Inc.; 2012.

[4] "What is Skin Cancer." SkinCancerNet. American Academy of Dermatology. Accessed on January 20, 2012. http://www.skincarephysicians.com/skincancernet/whatis.html

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