Navigation Links
FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
Date:6/5/2008

- Revised label includes data showing 35% reduction in new clinical

fractures in patients treated with Reclast following a recent hip

fracture(1) - Few patients currently receive osteoporosis treatment following hip

fracture despite high risk of morbidity and mortality(2) - Safety and efficacy profile of Reclast, already approved for treatment of

postmenopausal osteoporosis(1), reinforced in revised label

EAST HANOVER, N.J., June 5 /PRNewswire/ -- The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast(R) (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture(1).

No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less)(1). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.

The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast(3).

"The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture(2)," said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. "In the first large scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture."

Osteoporosis is a condition in which the bones become weak and can break more easily(4). Around 10 million people in the US are
'/>"/>

SOURCE Novartis
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
2. Plavix(R) Indications Expanded in Japan to Include Patients with Acute Coronary Syndrome for Whom Percutaneous Coronary Intervention Is Being Planned
3. ActivBiotics Receives Orphan Drug Designation from the European Medicines Agency for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis Indication
4. More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
5. ESBATechs Lead Antibody Fragment Enters Clinical Development for Ophthalmic Indications
6. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
7. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
10. Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids
11. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/7/2015)... , July 7, 2015 ... la société P&R annonce l,acquisition de 20% ... au niveau mondial, spécialisée dans la fabrication ... base d,acide hyaluronique.      (Logo: ... l,un des principaux groupes chimiques et pharmaceutiques ...
(Date:7/7/2015)... , June 30, 2015 ... the addition of the "Deciphering Global Major ... report to their offering. It has ... have been involved in a series of challenges ... has resulted in significant overcapacities in small molecule ...
(Date:7/7/2015)... , 7. Juli 2015 ... -Technik für klinische Studien, gab heute bekannt, dass ... führendes Unternehmen bei Gewinnung und Erhalt von Patienten ... Tochtergesellschaften MediciGlobal , Ltd. und Access to ... auch einen Dienst zum Auffinden von Patienten, die ...
Breaking Medicine Technology:Deciphering Global Major Pharmaceutical Companies - New Outsourcing Demands and Strategies 2Deciphering Global Major Pharmaceutical Companies - New Outsourcing Demands and Strategies 3BioClinica übernimmt MediciGroup 2BioClinica übernimmt MediciGroup 3BioClinica übernimmt MediciGroup 4
... 24, 2011 Codexis, Inc. (Nasdaq: ... launch, its Codex® Screening Kits are in use ... pharmaceutical companies worldwide.  The announcement was made at ... here this week.   Codex® Screening ...
... Oct. 24, 2011 Prometheus Laboratories Inc., a ... commercial launch of its proprietary PROMETHEUS® IBD sgi ... Prometheus, 4th-generation IBD diagnostic test and the first ... inflammation markers, hence "sgi", in the proprietary Smart ...
Cached Medicine Technology:50 Pharma Companies Worldwide Now Use Codexis In Process Development 2Prometheus Launches Next Generation IBD Diagnostic Test 2
(Date:7/7/2015)... ... July 07, 2015 , ... Dermatologists ... Aspen Ideas Festival (AIF), identifying 18 possible melanomas and 46 potential non-melanoma skin ... with additional testing. , The Aspen Ideas Festival, which was held from June ...
(Date:7/7/2015)... ... July 07, 2015 , ... ... that the two firms have merged to form Camber Collective. Camber Collective ... sectors. The merger combines SwitchPoint’s strategy consulting expertise with Hope Consulting’s deep ...
(Date:7/7/2015)... ... July 07, 2015 , ... Illinois cannabis cultivation ... limited to permit holders. The Medical Cannabis Alliance of Illinois’ (MCAI) board and ... and are committed to making sure patients have access to cannabis as a ...
(Date:7/7/2015)... ... July 07, 2015 , ... Summer is a great ... however, so Amica Insurance is sharing some safety tips. , Jean Tapley, senior wellness ... , Leisure activities/sports, , Start slowly. Going from no activity ...
(Date:7/7/2015)... Michigan (PRWEB) , ... July 07, 2015 , ... ... the heart of Downtown Detroit was the site of the National Baptist Convention ... Wellness Initiative. Focusing on encouraging and promoting the collaboration of churches and their ...
Breaking Medicine News(10 mins):Health News:More than 700 Screened for Skin Cancer at 2015 Aspen Ideas Festival 2Health News:More than 700 Screened for Skin Cancer at 2015 Aspen Ideas Festival 3Health News:More than 700 Screened for Skin Cancer at 2015 Aspen Ideas Festival 4Health News:SwitchPoint and Hope Consulting Have Merged to Form Camber Collective 2Health News:Cannabis Growers and Dispensaries Form Medical Cannabis Alliance of Illinois 2Health News:Amica Insurance Has 7 Summer Safety Tips 2Health News:A Forever Recovery CEO Per Wickstrom Speaks to Audience at National Baptist Convention's 11th Annual Health Fair 2Health News:A Forever Recovery CEO Per Wickstrom Speaks to Audience at National Baptist Convention's 11th Annual Health Fair 3
... ... announced the completion of over a dozen more HL7 interfaces with ... medical industry. pMDsoft,s industry-leading interface engine has allowed it to ... and increasing the accuracy of their claims. The variety of ...
... LISBON, Portugal, September 9 , - ... Could be the key to Improvement , ... of breakthrough pain[1] were presented today at the 6th congress,of the ... Pain (EFIC). , (Logo: http://www.newscom.com/cgi-bin/prnh/20090909/358726 ...
... owners and employees are among those who stand to ... current health reform proposals under consideration by Congress according ... to extend health care coverage to everyone and repair ... costs, high broker fees, underwriting, and a lack of ...
... , , JACKSONVILLE, Fla., Sept. ... of its stroke and traumatic brain injury treatment data at the ... in New York City this Friday, September 11, 2009, at 3:15 ... novel use and route of administration of an FDA-approved drug that ...
... , , KATHMANDU, ... real, life-saving results I personally saw in the eyes of your ... Ansari to Clark Carr, president of the international Narconon network, in ... Carr at the conclusion of an August 2009 technical and administration ...
... SACRAMENTO, Calif., Sept. 8 , , , WHEN: ... West Convention Center, San Francisco, CA ... Jessica Joisten ... Dental Association, will bring together some of ...
Cached Medicine News:Health News:pMDsoft Announces Interfaces with Additional EMR, EHR, Practice Management, Hospital and Billing Systems 2Health News:pMDsoft Announces Interfaces with Additional EMR, EHR, Practice Management, Hospital and Billing Systems 3Health News:pMDsoft Announces Interfaces with Additional EMR, EHR, Practice Management, Hospital and Billing Systems 4Health News:pMDsoft Announces Interfaces with Additional EMR, EHR, Practice Management, Hospital and Billing Systems 5Health News:First Results From Major European Patient Survey Show Devastating Impact of Living With Breakthrough Cancer Pain 2Health News:First Results From Major European Patient Survey Show Devastating Impact of Living With Breakthrough Cancer Pain 3Health News:Small businesses would see lower costs, more comprehensive coverage from health reform 2Health News:Small businesses would see lower costs, more comprehensive coverage from health reform 3Health News:Nepali Home Minister Commends Narconon International for Saving Lives 2Health News:California Dental Association to Showcase Critical Role of Dentists in Identifying and Treating Sleep Disorders 2Health News:California Dental Association to Showcase Critical Role of Dentists in Identifying and Treating Sleep Disorders 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
... 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: