Navigation Links
FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Date:9/19/2011

women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.  In these patients with prostate cancer, Prolia reduced the incidence of vertebral fractures.

Prolia is approved in the European Union (EU) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

Prolia is approved in the U.S., Canada, Australia, and in all 27 EU member states as well as in Norway, Iceland and Liechtenstein. Applications in the rest of the world are pending.

Prolia is administered as a single subcutaneous injection of 60 mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit: www.prolia.com.  

Important U.S. Safety Information

Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D. Patients receiving Prolia should not receive XGEVA®, as both Prolia and XGEVA contain the same active ingredient, denosumab.

In the Phase 3 pivotal study of women with postmenopausal osteoporosis (n=7808), serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group.
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... SHANGHAI , Oct. 22, 2014 /PRNewswire/ ... FMI ) and WuXi PharmaTech (Cayman) Inc. (NYSE: ... Foundation Medicine,s comprehensive genomic profiling to biopharmaceutical companies conducting ... Under the terms of the collaboration, Foundation ... laboratory component of Foundation Medicine,s FoundationOne® assay at the ...
(Date:10/20/2014)... VIEW, California , 20 de octubre de ... líder en el campo de la pulmonología intervencional, ... su Estudio RENEW, casi 3 meses antes de ... fundamental de exención de dispositivo de investigación (IDE) ... Medicamentos) para el sistema de espiral de reducción ...
(Date:10/20/2014)... ENGLEWOOD, Colo. , Oct. 20, 2014 /PRNewswire/ ... Inc. (NYSE MKT: AMPE), today announced that its ... the clinical and research potential for its novel ... oxidation-reduction potential (ORP) in the body in response ... clinical value of ORP as a clinical marker ...
Breaking Medicine Technology:Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 2Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 3Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 4Foundation Medicine and WuXi PharmaTech Announce Strategic Collaboration to Offer Best-in-Class Comprehensive Genomic Profiling in China 5PneumRx concluye inscripción en prueba fundamental RENEW 2PneumRx concluye inscripción en prueba fundamental RENEW 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 2Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 3Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 4Luoxis to Highlight RedoxSYS at Two Upcoming Scientific Conferences 5
(Date:10/22/2014)... October 22, 2014 Medical ... company, is happy to announce that our co-founder ... Staffing Industry Analysts’ Staffing 100 for 2014. Anderson ... “100 most influential people in the staffing industry,” ... Solutions, the 13th-largest healthcare staffing company in the ...
(Date:10/22/2014)... Shriners Hospitals for Children® and UK HealthCare have ... of Shriners Hospitals for Children - Lexington from 1900 ... of Kentucky Albert B. Chandler Hospital. The new facility ... operated by Shriners Hospitals for Children, and designed to ... families well into the future. , “The quality care ...
(Date:10/22/2014)... October 22, 2014 Best Cheap Hosting ... the world. The site has recently announced that iPower ... supplier for people from around the world. , “iPower ... operation today and is providing various kinds of useful ... company insists on offering excellent customer service and a ...
(Date:10/22/2014)... PA (PRWEB) October 22, 2014 Richard ... as an industry leader with over 25 years experience. ... team leader in the areas related to EDI, B2B ... Carlson is an Editorial Advisory Board member for Pharmaceutical ... Educator. Blue Fin Group is a management and ...
(Date:10/22/2014)... Tara Haelle HealthDay Reporter ... among young adult men may lead to increased blood pressure, ... cause a similar rise in blood pressure for young adult ... when young adult women drank lightly or moderately, their risk ... found. "This finding parallels studies in older adult men ...
Breaking Medicine News(10 mins):Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Best Cheap Hosting USA Has Recently Announced The Best Cheap Web Hosting Companies In 2014 2Health News:Rich Carlson and Marc Duey to Hold Workshop at CBI’s Specialty Pharmacy and Distribution Networks Conference 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4
... ANA, Calif., Nov. 16 Integrated,Healthcare Holdings, Inc. ... Orange County, California hospitals, has reported its financial,results ... Second Quarter Results IHHI reported consolidated ... months ended September 30, 2007, an increase of ...
... football, family and the enticing aromas of turkey,stuffing, yams ... a,Thanksgiving spread, one dish nobody anticipates is a hand ... the Hand cautions,carvers to take steps to carve the ... year during Thanksgiving, and throughout the holiday season,people sustain ...
... Whip,Roy Blunt (Mo.) issued the following statement today ... spending demands from,$22 billion to $11 billion:, ... their demand,for increased government spending from $22 billion ... anything about which programs,would receive more or less ...
... The President,s Council on,Physical Fitness and Sports ... as Science Partner on Friday, Nov 16, during,APTA,s ... "The President,s Council recognizes and values APTA,s ... therapist practice," said,Melissa Johnson, executive director of PCPFS. ...
... to satisfy all requirements for continued listing and make ... all necessary filings by December 31, 2007, ... (Nasdaq: MRGE ; TSX: MRG) (the,"Company") today announced that ... NASDAQ Stock Market on November 13, 2007, stating,that the Company,s ...
... to Impose Stiffer Penalties, ... State Investigators, CLAREMONT, Calif., Nov. 16 ... action lawsuit against Health Net,Life Insurance Company, alleging ... insurance policies has needlessly placed the,lives of hundreds ...
Cached Medicine News:Health News:IHHI Announces Second Quarter Earnings 2Health News:IHHI Announces Second Quarter Earnings 3Health News:Holiday Hand Safety 101: Hand Surgeons Offer Tips for a Safe Carving Season 2Health News:American Physical Therapy Association Named Science Partner to the President's Council on Physical Fitness and Sports 2Health News:Merge Technologies Receives Expected Additional NASDAQ Notification 2Health News:Merge Technologies Receives Expected Additional NASDAQ Notification 3Health News:Health Net Hit With Class Action Alleging Unfair Business Practices Over Retroactive Cancellations of Health Insurance Policies 2Health News:Health Net Hit With Class Action Alleging Unfair Business Practices Over Retroactive Cancellations of Health Insurance Policies 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: