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:5/27/2015)... REDWOOD CITY, Calif. , May 27, 2015  Genomic ... Brad Cole , Chief Operating Officer and Chief Financial Officer, ... New York City on Monday, June ... access the live and subsequently archived webcast of the presentation, ... site at http://investor.genomichealth.com .  Please connect to the web ...
(Date:5/27/2015)... FARMINGTON, Conn. , May 27, 2015  Nurtur ... Corporation (NYSE: CNC ), was recently honored by ... for its innovative Asthma Management Program delivered to Peach ... The Case in Point Platinum Awards ... and effectiveness across a variety of disciplines and settings ...
(Date:5/27/2015)... Calif. , May 27, 2015  Abaxis, Inc. ... point-of-care blood analysis systems, announced today that Ross ... relations, transitioning into the role of chief financial officer ... 2015 Global Healthcare Conference on Thursday, June 4, 2015 ... at the Grand Hyatt in New York ...
Breaking Medicine Technology:Genomic Health to Present at the Jefferies 2015 Global Healthcare Conference 2Genomic Health to Present at the Jefferies 2015 Global Healthcare Conference 3Nurtur's Asthma Management Program Wins Award from Dorland Health 2
... AccessClosure, Inc., a leading manufacturer of extravascular closure ... Mynx unit. The Mynx Vascular Closure Device received its ... commercial launch in September 2007. Physician feedback attributes the ... the Mynx sealant is extravascular, bio-inert and non-thrombogenic, while ...
... 2011 Visiting Nurse Services of Connecticut, one ... agencies, announces that it has entered into a ... telehealth technology to patients with chronic conditions using ... Telehealth(SM), is a world class developer, manufacturer and ...
Cached Medicine Technology:AccessClosure, Inc. Marches to the Millionth Mynx! 2Visiting Nurse Services of Connecticut Selects Cardiocom® As Its New Telehealth Vendor 2
(Date:5/27/2015)... Jose, CA (PRWEB) May 27, 2015 Splashtop ... its latest addition to its screen mirroring and extended display ... Whether in a conference room, classroom, or family room, users ... a large TV / display connecting to an Apple TV, ... Amazon Fire TV, Amazon Fire TV Stick, or the Google ...
(Date:5/27/2015)... CRN International, the radio marketing and promotions ... Financial Officer. , Prinner most recently was Principal of ... financial/operational executive positions at telecom and technology services companies ... and SNET. His accounting and consulting career began ... will be able to tap into his experience of ...
(Date:5/27/2015)... Louisville, KY (PRWEB) May 27, 2015 ... or worse because of lack of compliance documentation or ... a recycler in Miami, a propane gas company in ... doling out fines for incidents and accidents due to ... System (LMS) is proud to introduce the new ...
(Date:5/27/2015)... TX (PRWEB) May 27, 2015 Congratulations ... The Torch” Addiction Treatment Scholarship Award. From June 1, ... $10,000 to 50 drug and alcohol addiction treatment centers ... treatment. Scholarships were drawn at random at addiction treatment ... for Sky Toxicology, Matt Green said, “Sky Toxicology would ...
(Date:5/27/2015)... 2015 Altec Products, Inc., a leader ... their Premier Sponsorship of Connections 2015. The all-day client ... Thursday, May 28th and will deliver to clients both ... the roadmap to get there. , Arxis Technology, ... sale, installation and support of Intacct Cloud Financials, Adaptive ...
Breaking Medicine News(10 mins):Health News:Splashtop Launches the Fastest Computer Screen Mirroring and Extended Display Solution – to Apple TV and other Smart Displays 2Health News:Splashtop Launches the Fastest Computer Screen Mirroring and Extended Display Solution – to Apple TV and other Smart Displays 3Health News:CRN International Names New Chief Financial Officer 2Health News:New Supervisor Feature Streamlines HR Compliance Reporting and Documentation 2Health News:New Supervisor Feature Streamlines HR Compliance Reporting and Documentation 3Health News:Sky Toxicology Reaches Their $500,000 Goal in Drug and Alcohol Addiction Treatment Patient Scholarship Awards 2Health News:Sky Toxicology Reaches Their $500,000 Goal in Drug and Alcohol Addiction Treatment Patient Scholarship Awards 3Health News:Altec Sponsors Connections 2015, Arxis Technology, Inc.’s Client Conference, Bringing Valuable Document Management Solution to Attendees 2Health News:Altec Sponsors Connections 2015, Arxis Technology, Inc.’s Client Conference, Bringing Valuable Document Management Solution to Attendees 3
... OUT TO EDUCATE CHICAGOANS, CHICAGO, Jan. 25 ... of Chicago, SAVE THE PATIENT, a,not-for-profit patient-focused organization, is ... Access Network (CAN-TV) and,will air on Monday, January 28, ... will feature a frank discussion on how to make ...
... study finds , , FRIDAY, Jan. 25 (HealthDay News) ... States hit $174 billion in 2007, a 32 percent ... research, commissioned by the American Diabetes Association (ADA), found ... $116 billion, and a disproportionate percentage of those costs ...
... Time with,Friends and Family, SACRAMENTO, Calif., Jan. 25 ... senior citizen center to enjoy the company,of other seniors. ... for her to go to the dining room, and ... donated by The SCOOTER Store,Mrs. Pittman can now enjoy ...
... needed to confirm the findings, experts say , , FRIDAY, Jan. ... lutein could lower a woman,s risk of sight-robbing cataracts, new ... 35,000 women aged 45 and older. , "The data suggests ... total vitamin E may have a lower risks of cataracts," ...
... Inc. (NYSE:,WLP) announced today that senior management is ... January 30, 2008. The presentation is,expected to begin ... interested parties are invited to listen to the ... and selecting the "Investor,Info" link. Following the presentation, ...
... WARSAW, Ind., Jan. 25 Symmetry Medical Inc.,(NYSE: ... to the global orthopaedic,device industry and other medical ... announced acquisition of DePuy Orthopaedics, Inc,s,facility for orthopaedic ... in cash., As originally announced in December ...
Cached Medicine News:Health News:Making the Most Out of Your Doctor's Visit 2Health News:Diabetes' Health Toll Hits $174 Billion Annually 2Health News:Disabled Sacramento Woman, 110, Receives Power Wheelchair Donation from The SCOOTER Store 2Health News:Vitamin E, Lutein May Fight Cataracts 2Health News:Vitamin E, Lutein May Fight Cataracts 3Health News:WellPoint Announces Appearance at Upcoming Conference 2Health News:Symmetry Medical Completes Acquisition of DePuy Orthopaedic Instrument Facility 2
... for catheter or instrument introduction. The ... be peeled away and removed. The ... instrument to be introduced should be ... the sheath. Supplied sterile in peel-open ...
Used to gain percutaneous access into the renal pelvis to treat stone disease. The dual lumen catheter and the Peel-Away® introducer are sized for use in pediatric patients. Supplied sterile in p...
Supplied sterile in peel-open packages. Intended for one-time use....
Used when establishing a percutaneous tract for nephrostomy drainage. The wire guide has an extra stiff shaft and a gradual transition to a very flexible tip. Supplied sterile in peel-open packages. ...
Medicine Products: