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

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.

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.


'/>"/>
SOURCE ETHICON, 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
2. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
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:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... 11, 2016  Neurocrine Biosciences, Inc. (NASDAQ: NBIX ) today ... 31, 2015. --> --> ... loss of $29.3 million, or $0.34 loss per share, compared to ... for the same period in 2014. For the year ended December ... or $1.05 loss per share, as compared to a net loss ...
(Date:2/11/2016)... Feb. 11, 2016  Spectra BioPharma Selling Solutions (Spectra) ... provides biopharma companies the experience, expertise, operational delivery ... outsourced sales teams. Created in concert with industry ... the strategic and tactical needs of its clients ... through both personal and non-personal promotion. ...
(Date:2/11/2016)... February 11, 2016 ... or "Company") (OTCQB: PSID), a life sciences company ... its Thermomedics subsidiary, which markets the Caregiver® FDA-cleared ... plan in January 2016, including entering into agreements ... monthly sales growth, and establishing several near-term pipeline ...
(Date:2/11/2016)... ... February 11, 2016 , ... Global Stem Cells Group, ... Quito, Ecuador. The new facility will provide advanced protocols and state-of-the-art techniques in ... world. , The new GSCG clinic is headed by four prominent Ecuadorian ...
Breaking Biology Technology:
(Date:1/22/2016)... , January 22, 2016 ... the addition of the  "Global Behavioral ... offering. --> http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) ... "Global Behavioral Biometric Market 2016-2020"  report ... Research and Markets ( http://www.researchandmarkets.com/research/4lmf2s/global_behavioral ) has ...
(Date:1/20/2016)... Jan. 20, 2016  Synaptics Incorporated (NASDAQ: ... solutions, today announced sampling of S1423, its newest ... and small screen applications including smartwatches, fitness trackers, ... round and rectangular shapes, as well as thick ... with moisture on screen, while wearing gloves, and ...
(Date:1/11/2016)... , Jan. 11, 2016 Synaptics Incorporated ... interface solutions, today announced that its ClearPad ® ... (TDDI) products won two separate categories in the 8 ... Innovator and Best Technology Breakthrough. The Synaptics ® ... a simplified supply chain, thinner devices, brighter displays and ...
Breaking Biology News(10 mins):