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JOHNSON & JOHNSON WOUND MANAGEMENT, a division of ETHICON, INC.
Press Release
ETHICON, INC. Announces Revised Label for REGRANEX (becaplermin) Gel 0.01%
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Setting the standard with technology-based solutions from the first name in wound care. From the first - ever sterile bandage to the most innovative developments in wound healing, Johnson & Johnson Wound Management continues to set new standards of care with technology-based solutions, supported by evidence, to advance the treatment of chronic wounds.

PATHways to Healing, our integrated approach to treating chronic wounds, is supported by the most comprehensive research in the industry. Our unique solutions, which address the underlying causes of impaired healing in chronic wounds, are engineered to help you prepare and close wounds faster.

Indication:
REGRANEX Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers (see Clinical Studies), and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.

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.

Click here for Full Prescribing Information for REGRANEX Gel.

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©ETHICON, INC. 2008