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ETHICON, INC. Announces Revised Label For REGRANEX(R) (becaplermin) Gel 0.01%
Date:6/6/2008

nical practice."

REGRANEX Gel, manufactured by OMJ Pharmaceuticals, Inc. for its distributor Ortho-McNeil, is commercialized in the United States by Johnson & Johnson Wound Management, a division of ETHICON, INC.

About REGRANEX Gel

REGRANEX Gel is the only FDA-approved prescription medicine that contains platelet-derived growth factor (PDGF), a substance that helps the body heal. It is applied directly to the ulcer. REGRANEX Gel, in conjunction with good wound care, has been proven to help heal diabetic ulcers more effectively than standard wound care. The product has been on the market for ten years and has been used to treat more than 750,000 patients.

Important Safety Information

REGRANEX Gel is contraindicated in patients with neoplasms at the site of application. An increased risk of mortality secondary to malignancy remote from the site of treatment has been observed in patients treated with 3 or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. (See Boxed WARNING). However, in a separate analysis of cancer incidence, these results were consistent with no overall increase in cancer incidence (See WARNINGS). REGRANEX Gel should be used with caution in patients with known malignancy. REGRANEX Gel is contraindicated in patients with known hypersensitivity to any component of this product (eg, parabens). Erythematous rashes occurred in 2% of patients treated with REGRANEX Gel or placebo gel. REGRANEX Gel should not be used in wounds that close by primary intention.

Please visit http://www.Regranex.com for the full Prescribing Information.

(C) ETHICON, INC. 2008 REGRANEX Gel is a registered trademark of Ortho-McNeil TM, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc.


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