Navigation Links
Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Date:8/19/2007

- Shown to be highly effective in strengthening bones and protecting

against osteoporosis-related fractures, including spine and hip - Reclast reduced spine fractures by 70% and hip fractures by 41% compared

to placebo in study published in New England Journal of Medicine - Unique once-yearly dosing provides potential for significant compliance

benefits

- Osteoporotic fractures affect one in two women over 50(1) and are

associated with increased morbidity, mortality and healthcare costs

EAST HANOVER, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Reclast(R) (zoledronic acid) Injection has been approved by the US Food and Drug Administration as the first and only once-yearly medicine for postmenopausal osteoporosis, offering an important new approach to the treatment of a bone disease affecting eight million women in the US(1).

Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment a patient can receive a full year's protection against the effects of osteoporosis -- a disorder that causes bones to break easily.

"The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis," said Felicia Cosman, MD, Professor of Clinical Medicine, Columbia University.

"For the first time we can ensure women receive a full year of the treatment they need to protect their bones," said Dr. Cosman.

The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the European Union, under the brand name Aclasta(R). The European Commission generally follows the CHMP's recommendations and is expected to issue a final decision within three months.

The regulatory subm
'/>"/>

SOURCE Novartis Pharmaceuticals Corporation

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5 6

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
5. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
6. Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
7. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
8. Ablynx Announces Interim Results of First Nanobody Phase I Study of ALX-0081 (ANTI-VWF)
9. Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial
10. Advanced Life Sciences to Host Conference Call to Discuss Data From Cethromycins First of Two Phase 3 Pneumonia Trials
11. First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... , August 27, 2015 According to ... (Transfer, Hammock, Toilet, Seating, Universal, Standing, Bariatric ), Material (Nylon, Padded, ... Forecast to 2020", published by MarketsandMarkets, the Medical Lifting Sling Market ... 411.5 Million in 2015, at a CAGR of 11.4 % from ... ma rket data T ables and ...
(Date:8/27/2015)... Ga. , Aug. 27, 2015  MiMedx Group, ... medicine company utilizing human amniotic tissue and patent-protected ... therapies for the Wound Care, Surgical, Orthopedic, Spine, ... responded today and corrected the multiple inaccuracies in ... Foundation ("MTF") regarding the recent rulings from the ...
(Date:8/27/2015)... August 27, 2015 According to ... by Type (Integrated, Standalone), by Deployment Mode (Web based, ... Emergency Healthcare Service Providers), by Component - Global Trends ... Market is estimated at $501.1 Million 2014, and is ... CAGR of 7.6% from 2014 to 2019. ...
Breaking Medicine Technology:Medical Lifting Sling Market Worth USD 706.0 Million by 2020 2Medical Lifting Sling Market Worth USD 706.0 Million by 2020 3Medical Lifting Sling Market Worth USD 706.0 Million by 2020 4MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 2MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 3MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 4Radiology Information Systems Market Worth $722.7 Million by 2019 2Radiology Information Systems Market Worth $722.7 Million by 2019 3Radiology Information Systems Market Worth $722.7 Million by 2019 4
... PRXL ) announced today it will be presenting ... von Rickenbach, Chairman and Chief Executive Officer will be making ... January 13, 2011. A live webcast of this ... of PAREXEL,s website at www.PAREXEL.com in the Upcoming ...
... Pharmaceuticals, Inc. (Nasdaq: AMLN ) will be presenting ... Francisco on Monday, January 10, 2011 at 4:30 p.m. ET ... and chief executive officer of Amylin Pharmaceuticals, will provide a ... be webcast through the "Investors" section of Amylin,s corporate website ...
Cached Medicine Technology:PAREXEL International to Present at J.P. Morgan Healthcare Conference 2
(Date:8/27/2015)... ... 27, 2015 , ... Zensah®, the premium athletic compression company, ... Israel in the Women’s Tennis Association (WTA). Glushko competes in tennis tournaments around ... With a focus on technology and comfort, Zensah® has developed compression gear to ...
(Date:8/27/2015)... and OKLAHOMA CITY, OK (PRWEB) , ... August ... ... Point Partners (“GPP”) I, LP portfolio company and leading biopharmaceutical contract development manufacturing ... be acquired by Hepalink USA Inc. (“Hepalink”) for $205.68M in cash. ...
(Date:8/27/2015)... ... August 27, 2015 , ... Susan Harris and ... relieve vaginal discomfort due to pre- and post-menopause, chemotherapy, and child birth. , ... which delivers controlled energy to the vaginal tissue, revitalizing cells so they make more ...
(Date:8/27/2015)... ... August 27, 2015 , ... NetDimensions is once again named among ... platforms required not only to effectively deliver, curate and administer great programs, but also ... , For six consecutive years, NetDimensions has maintained its position on this Top ...
(Date:8/27/2015)... Winchester, MA (PRWEB) , ... ... ... Group, Inc., an executive management consulting firm that helps libraries, publishers and ... DuraSpace Registered Service Provider (RSP) for the VIVO Project. Gunter Media Group, ...
Breaking Medicine News(10 mins):Health News:Zensah® Compression Announces Partnership with WTA Tennis Professional Athlete, Julia Glushko 2Health News:Zensah® Compression Announces Partnership with WTA Tennis Professional Athlete, Julia Glushko 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 2Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 3Health News:Great Point Partners, LLC Announces that Hepalink USA Inc. Agrees to Acquire Cytovance Biologics, Inc. 4Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 2Health News:LifeStream Health Centre & MedSpa Announces New Treatment for Vaginal Discomfort 3Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 2Health News:NetDimensions Named Among Top 20 Learning Portal Companies of 2015 3Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 2Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 3
... 11, 2011) According to new research by University ... treating a variety of diseases may produce unintended and ... Induce Retinal Degeneration via TLR3 and IRF3", appears in ... Therapy, a publication of the Nature Publishing Group ...
... Okla. From the barren arctic tundra to the ... of creatures seems to increase as ambient temperatures rise. ... has ever examined the reasons behind differences in populations ... and Jizhong Zhou, professors in the University of Oklahoma ...
... separated from an abusive partner, the violence still costs Canadians an ... of British Columbia. Led by UBC Nursing Prof. Colleen Varcoe, ... Public Policy is the first in Canada to comprehensively ... who leave a violent partner. Overall, the annual bill ...
... KAMPALA, Uganda A pioneering international collaboration forged ... Wash., USA, together with the Uganda Cancer Institute ... future construction of a state-of-the-art cancer training and ... be the first comprehensive cancer center jointly constructed ...
... Oct. 11, 2011A total of 606 Canadian physicians were ... and 2009, researchers at St. Michael,s Hospital found. ... cent) who had been practicing medicine for a long ... practitioners (99 per cent), according to Dr. Chaim Bell. ...
... (HealthDay News) -- Environmental pollutants such as dioxins, PCBs ... (atherosclerosis), according to a new study. Atherosclerosis is ... the most common cause of death in industrialized countries, ... They measured levels of persistent (long-lived and hard to ...
Cached Medicine News:Health News:Emerging pharmaceutical platform may pose risks to retinal health 2Health News:OU professors awarded $2.8 million for 4-year study on biodiversity in warmer climates 2Health News:Annual cost of violence pegged at $6.9 billion after women leave abusive partners, UBC research 2Health News:Hutchinson Center breaks ground for first collaborative cancer center in sub-Saharan Africa 2Health News:Hutchinson Center breaks ground for first collaborative cancer center in sub-Saharan Africa 3Health News:Hutchinson Center breaks ground for first collaborative cancer center in sub-Saharan Africa 4Health News:Hutchinson Center breaks ground for first collaborative cancer center in sub-Saharan Africa 5Health News:Researchers track number of doctors disciplined and why 2Health News:Environmental Toxins Linked to Hardening of Arteries 2
The balloon catheter is designed to pass over a previously placed .015 inch diameter wire guide included. Supplied sterile in peel-open packages. Intended for one-time use....
Radiopaque markers are placed at the proximal and distal ends of the balloon. A special pin vise handle is included to stabilize the wire guide during introduction. Supplied sterile in peel-open pack...
Radiopaque markers are placed at the proximal and distal ends of the balloon. A special pin vise handle is included to stabilize the wire guide during introduction. Supplied sterile in peel-open pack...
... Technologies, The UroMax Ultra ia designed ... high pressure and low profile., Refolding ... a remarkably strong material that is ... materials., Non-Compliant Balloons, A compliant balloon ...
Medicine Products: