Navigation Links
ETHICON, INC. Announces Revised Label For REGRANEX(R) (becaplermin) Gel 0.01%

SOMERVILLE, N.J., June 6 /PRNewswire/ -- ETHICON, INC. today announces revised labeling for REGRANEX Gel, a topical formulation of recombinant human platelet-derived growth factor indicated as an adjunct to the treatment of lower extremity diabetic neuropathic ulcers.

The WARNINGS section of the label has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for it. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to REGRANEX Gel to 2,809 matched comparators. The results were consistent with no overall increase in cancer incidence among patients exposed to REGRANEX Gel, however, there was a five- fold increased risk of cancer mortality in the group exposed to three or more tubes of REGRANEX Gel, based on four cases. The types of cancers varied and were remote from the treatment site.

The BOXED WARNING states "An increased rate of mortality secondary to malignancy was observed in patients treated with three or more tubes of REGRANEX Gel in a post-marketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy."

The Company has worked closely with the FDA to ensure that the REGRANEX Gel label provides physicians and patients with the information they need to make the most appropriate and informed treatment decisions. ETHICON, INC. is committed to broadly disseminating this new prescribing information about the safety of REGRANEX Gel through a "Dear Healthcare Professional" letter and its field-based employees.

"We remain confident in the safety and efficacy of REGRANEX Gel when used according to its label," said James C. Hart, MD, Vice President, Global Medical Affairs, ETHICON. "The benefits of REGRANEX Gel have been established in well-controlled studies and confirmed in clinical 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.


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 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.

Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
4. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
5. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
6. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
11. CNS Response Announces Fiscal Third Quarter 2007 Results
Post Your Comments:
(Date:10/8/2015)... Life Sciences Inc. (OTCQB: REPCF) (TSX.V: RP), a clinical ... autologous cell therapies, today announced its schedule of upcoming presentations ... month of October: Stem Cell Meeting on ... presenting at the annual Partnering Forum, part of the ... October 7-9 in La Jolla, California ...
(Date:10/8/2015)... ... 2015 , ... Cystic fibrosis (CF) is a genetic disease ... results in dysfunction of the lungs and the gastrointestinal (GI) tract. In CF ... very difficult to clear, blocks the airways and the glands, and creates an ...
(Date:10/7/2015)... Calif. , Oct. 7, 2015  ChromaDex ... wellness and nutritional ingredients that creates science-based solutions ... sports nutrition, and pharmaceutical products, today announced that ... , CEO and Founder, is now available for ...   -->   ...
(Date:10/7/2015)... , Oct. 7, 2015   Intrexon Corporation ... today announced it will hold an Investor Day in ... afternoon of Thursday, November 12, 2015. Intrexon,s Chairman and ... other members of the Company,s management team as well ... focus on strategic initiatives, product pipeline, and program updates ...
Breaking Biology Technology:
... drive to make healthcare information technology interoperable across ... and a medical information technology company headquartered here ... is lending its expertise to developing an ... the healthcare industry. Specifically, the expertise of Damien ...
... Sonic Foundry, Inc. has announced that it ... the fourth quarter of 2006, its first cash-positive quarter ... been building toward profitability since moving into the rich-media ... which the company showcased new search technology. , ,The ...
... . - Following weeks of blistering criticism of its electronic ... Foundation Health Plan , Madison's Epic Systems Corp . ... defending its product. , ,Epic Systems, a medical software developer, ... its electronic records system, which Kaiser has re-branded with the ...
Cached Biology Technology:
(Date:9/30/2015)... , Sept. 30, 2015  The global glucose monitoring ... for 2015. So says a new report on the industry ... management segment dominate the market, followed by continuous glucose monitoring ... reports on the market for these products in its latest ... ...
(Date:9/28/2015)... 2015  The monitoring of vital signs, such ... is an essential component of patient assessment. Changes ... in a patient,s condition. However, in general care ... taken during routine observation rounds only once every ... between these observation rounds, the warning signs can ...
(Date:9/26/2015)... 2015  Results of a TactioRPM pilot project ... at the Stanford Medicine X Conference. In a ... Connected Health Devices and Pharmacogenomics", Roger Simard ... explain how senior patients equipped with connected health ... via the TactioRPM remote patient monitoring platform were ...
Breaking Biology News(10 mins):
... in traffic may cause a headache, but a delay ... of Missouri researchers have uncovered clues identifying which proteins ... and found that the proteins previously thought to play ... the nervous system develops will give researchers a better ...
... A team of Vanderbilt University Medical Center investigators has ... a new class of drugs for treating cancer., The ... phospholipase D (PLD), an enzyme that has been implicated ... colorectal., The new inhibitors, reported in the February issue ...
... gardening can offer enough moderate physical activity to keep older ... February in the journal HortScience , the researchers discovered ... older hands strong and nimble. "One of the things ... better hand strength and pinch force, which is a big ...
Cached Biology News:
Anti-NCAPD3 Monoclonal AntibodyOther Sub-Family: not assigned-Other Applications: Immunoprecipitation, Western Blot...
... Lyophilized solid. Supplied as a ... UNDER INERT GAS. A cell-permeable mutated analog ... 196810) that serves as a negative control. ... Purity: ≥97% by HPLC. Soluble ...
BD Falcon microtest assay plate. 1536 well 12l, black, flat-bottom PS. Polystyrene, nonsterile, no lid. (15/sp, 60/ca) Packaging: 15 / pack, 60 / case ...
... flexible, fully automated microplate strip washer for 96- ... automated microplate strip washing capability, the Columbus combines ... operation. , Features ... 8, 12 or 16 channels, crosswise aspiration, overflow ...
Biology Products: