Navigation Links
Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) for the Treatment of Advanced Breast Cancer
Date:9/10/2009

HORSHAM, Pa., Sept. 10 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

Centocor Ortho Biotech is evaluating the FDA's letter and will respond to the agency as quickly as possible.

The sNDA for DOXIL was submitted to the FDA in September 2008. DOXIL currently is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. DOXIL in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. DOXIL is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

DOXIL is marketed in the United States by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as CAELYX throughout the rest of the world, excluding Japan and Israel. For more information about DOXIL, please visit www.DOXIL.com.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS:

Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution

  • The use of DOXIL may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative do
    '/>"/>

SOURCE Centocor Ortho Biotech Products, L.P.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Medarex Announces Extension of Broad Antibody Development Relationship with Centocor
2. Centocor Announces Ustekinumab Biologic License Application Accepted for Filing by FDA
3. Centocor/Janssen-Cilags Ustekinumab Will Become the Gold Standard for Psoriasis By 2011
4. Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
5. Ortho Biotech, L.P. and Centocor, Inc. Alert Authorized Distributors and Prescribing Physicians About Stolen Product
6. GeneNews provides Centocor access to its osteoarthritis program
7. Baseline Research Indicates High Interest in Centocor-Ortho Biotechs SIMPONI(R)
8. Centocor Ortho Biotech Data to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting
9. Centocor Ortho Biotech Inc. Awarded $1.67 Billion Patent Jury Verdict from Abbott Laboratories
10. Ortho Biotech Supports FDA Advisory Committees Recommendations on Use of ESAs in Chronic Renal Failure Patients
11. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2015)... 2015  Eli Lilly and Company (NYSE: LLY ... cancer therapies, reflecting Lilly,s diverse oncology pipeline, during the ... held April 18-22 in Philadelphia , ... is the theme of this year,s AACR meeting and ... its portfolio of therapies that accelerate the pace and ...
(Date:4/20/2015)... Sinovac Biotech Ltd. (Nasdaq: SVA), a leading ... unaudited financial results for the fourth quarter and full ... 2014 Financial Highlights(Compared to the fourth quarter 2013) ... of 11.4% from $22.9 million in the prior year ... pandemic influenza vaccine of $0.1 million in the fourth ...
(Date:4/18/2015)... PHILADELPHIA , April 18, 2015 ... (NASDAQ: CRIS ) will be presenting data ... the American Associate of Cancer Research Annual Meeting ... ).      (Logo: http://photos.prnewswire.com/prnh/20130418/608115 ) ... its proprietary Nicotinamide phosphoribosyltransferase (NAMPT) small molecule inhibitors ...
(Date:4/17/2015)... 17, 2015 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD; ... that develops and commercializes proprietary technologies and products ... it has received approval from the TSX Venture ... common share purchase warrants ("the Warrants") of the ... Company,s May 2013 private placement financing. ...
Breaking Biology Technology:Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 2Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 3Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 4Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 5Lilly Releases Early-Stage Pipeline Data at AACR Annual Meeting 2015 6Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 2Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 3Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 4Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 5Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 6Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 7Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 8Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 9Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 10Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 11Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 12Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 13Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 14Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 15Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 16Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 17Sinovac Reports Unaudited Fourth Quarter and Full Year 2014 Financial Results 18Aurigene to Present its NAMPT and IRAK-4 Inhibitors Programs at AACR 2015 2SQI Diagnostics to Extend Warrant Expiry 2SQI Diagnostics to Extend Warrant Expiry 3
... , a provider of molecular diagnostics solutions, reported losses in ... Wave reported total revenue of $5.8 million and a net ... for the quarter ended June 30, 2005, compared to total ... and zero cents per diluted share for the same period ...
... Third Wave Technologies Inc., a developer and provider ... chairman of the company's board of directors, replacing company ... the business's planned transition. , ,Thompson, 63, was the ... of Abbott Laboratories , an Illinois-based medical products ...
... Corp ., a Waukesha-based supply chain technology ... enabling Cooper Lighting , a George-based ... distribution operations and workforce productivity. , ,The ... with RedPrairie's DLx Warehouse, slotting and workforce ...
Cached Biology Technology:Transition continues to impact Third Wave financials 2
(Date:4/2/2015)... Fingerprint Cards (FPC) has received ... the distributor World Peace Industrial Group (WPI), part of ... the major part of the shipments will take place ... smartphone manufacturers in China . The ... communicated revenue guidance of + 1 000 MSEK for 2015.  ...
(Date:3/30/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/lc9bnl/global_gesture ) has ... Market in Automotive Sector 2014-2018" report to their ... Recognition market in Automotive Sector to grow at a ... Gesture recognition is the ability of a device to ... Gesture recognition technology can be 2D-based or 3D-based. It ...
(Date:3/24/2015)... GARDENS, Fla. , March 24, 2015 /PRNewswire/ ... identity management solutions, today announced that its U.are.U ... clothing accessory retailer Goorin Bros . to ... Crossmatch biometrics-based solution secures access to the POS ... the increased risk of data breaches. ...
Breaking Biology News(10 mins):Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 110 Million 2Global Gesture Recognition Market in Automotive Sector Report 2015 - Growing Number of Partnerships 2Crossmatch Fingerprint Readers Help Retailer Prevent Data Breaches at Point-of-Sale 2
... of a new gene is helping researchers at Michigan ... A team of researchers, led by Katherine Osteryoung, ... a new class of proteins in the ... Academy of Sciences . CLMP1 plays a key role ...
... aid cavity-nesting ducks can prove to be turtle death traps. ... Educator Associate Professor Denis Conover, of the Department of Biological ... he came upon a duck nest box in the wetlands ... over. Turtle corpses were strewn about the mud and mire ...
... living in family or group homes are less ... living in institutions, according to University of Louisville ... Ph.D. These individuals also are more likely than ... increased decay and gum disease, factors that may ...
Cached Biology News:Discovery of new gene could improve efficiency of molecular factories 2UC research finds that a duck's boon might be a turtle's bane 2UofL researcher to develop oral health plan for those with IDD 2