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:10/22/2014)... Oct. 21, 2014   BioNano Genomics , ... genomics research centers to purchase an Irys™ System ... National Cancer Institute (NCI), NIH Intramural Sequencing Center (NISC) ... Irys, obtaining a comprehensive view of a genome ... (NGS) does not deliver the scalability or reliability ...
(Date:10/22/2014)... 2014 InVivo Therapeutics Holdings Corp. (OTCQB: NVIV) ... revolutionizing spinal cord injury (SCI) treatment with their novel ... in tissue regrowth in the spinal cord area when ... FDA approved polymer, the scaffold ultimately breaks down to ... human body. NVIV has recently attracted significant investor attention ...
(Date:10/22/2014)... Calif. , Oct. 22, 2014  AcelRx ... announced that results from the  IAP310 study have ... Medicine (RAPM), a peer-reviewed journal with broad, ... 3 trial evaluating the safety and efficacy of ... tablet system (SSTS), for the treatment of post-operative ...
Breaking Medicine Technology:BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 2BioNano's Irys System Adopted by Leading Genomics Centers for Comprehensive Detection of Human Genome Structural Variation 3InVivo Therapeutics Analyst Coverage Initiated: Analyst Report by BrokerBank Securities, Inc. 2InVivo Therapeutics Analyst Coverage Initiated: Analyst Report by BrokerBank Securities, Inc. 3AcelRx Announces Publication of Zalviso Phase 3 Abdominal Trial Results 2
(Date:10/22/2014)... By Maureen Salamon ... -- A crucial part of conventional in vitro fertilization (IVF) ... can instead take place in a device inside the vagina, ... Colombia contend that the device, called an INVOcell, might sharply ... could also make the technology more accessible to those who ...
(Date:10/22/2014)... HealthDay Reporter TUESDAY, Oct. 21, 2014 ... while working for NBC News in Liberia has cleared ... unit at Nebraska Medical Center in Omaha, where he had been ... A blood test confirmed by the U.S. Centers for Disease Control ... Providence, R.I., NBC News reported Tuesday night. "Recovering ...
(Date:10/20/2014)... October 20, 2014 Allegheny General Hospital’s ... that enables physicians to repair a damaged mitral valve ... MitraClip system, developed by Abbott Vascular , ... progressive and life-threatening condition in which the heart’s mitral ... flow backward from the heart’s left ventricle into the ...
(Date:10/20/2014)... 2014 Women’s health specialist, Dr. Amber ... Gynecology of Columbus, Inc., A Division of MaternOhio Clinical ... more than 100,000 patients annually. Dr. Murphy will provide ... stages of a women’s life. She is accepting new ... Westerville and Dublin. , Dr. Murphy offers a wide ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Zereana Jess-Huff, a ... Mrs. Maryland 2014 on a platform to think outside the ... and uses her position to raise awareness about women’s other ... for breast cancer. You say the color pink and everybody ... know for a fact that it has not been won ...
Breaking Medicine News(10 mins):Health News:Experimental Infertility Treatment Seems Effective, Cheaper 2Health News:Experimental Infertility Treatment Seems Effective, Cheaper 3Health News:Experimental Infertility Treatment Seems Effective, Cheaper 4Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 2Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 3Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 2Health News:Ovarian Cancer Survivor Mrs. Maryland Urges Media to Think Outside the Bra 3
... of Cost-Effective High-Quality Home Infusion Can be ... WASHINGTON, March 5 Patients on Medicare ... Johnny Isakson (R-GA) and Representative Eliot L. ... a flaw in the Medicare program which ...
... YORK (March 5, 2009) -- Two highly lethal viruses that ... established drug used to prevent and treat malaria, according to ... Medical College in the Journal of Virology . Due ... advance of the first April print issue. , The two ...
... of Nutrition and Physical Activity at the Indiana State ... GoTrybe.com to provide Indiana kids and teens with a ... fun. Young Hoosiers can enjoy FREE memberships to the ... www.GoTrybeIN.com . A 2007 Youth Risk Behavior Survey showed ...
... the commercial printing superstore was honored for ecommerce expertise when President ... the online version of the highly respected Entrepreneur magazine. , ... ... selected Mr. Del Chiaro for the interview based on his proven ...
... on annual listOAKLAND, Calif., March 5 ... been recognized by DiversityMBA ... was ranked No. 1 in the publication,s fourth annual ... Diverse Managers to Work," which will hit newsstands in ...
... don,t offer emergency contraception pills to adolescents who ... because of misinformation about how the medicine works, ... of Philadelphia. Improved physician education may increase prescription ... said. Researchers surveyed 291 members of the ...
Cached Medicine News:Health News:Patients, Senate, House Members Identify Significant Medicare Savings While Increasing Quality of Patient Care 2Health News:Patients, Senate, House Members Identify Significant Medicare Savings While Increasing Quality of Patient Care 3Health News:Drug blocks 2 of world's deadliest emerging viruses 2Health News:Drug blocks 2 of world's deadliest emerging viruses 3Health News:GoTrybe.com Launched in Indiana to Promote Children's Health 2Health News:My1Stop.com President Michael Del Chiaro Interviewed by Entrepreneur.com for ecommerce Expertise 2Health News:Kaiser Permanente Recognized as Best Place for Diverse Managers 2Health News:Kaiser Permanente Recognized as Best Place for Diverse Managers 3Health News:Research Says Better Physician Education Would Improve Hospital Prescription of Emergency Birth Control to Teens 2Health News:Research Says Better Physician Education Would Improve Hospital Prescription of Emergency Birth Control to Teens 3
RCB™ Rotator Cuff Buttress is a completely resorbable plate that will alleviate suture migration in open or mini-Open rotator cuff repairs....
... The E-Z Tac™ implantThe USS Sports Medicine™ ... used to attach soft tissue to bone. The ... hole in the bone and is used to ... is made of a resorbable copolymer, a polyester ...
... Medicine™ AnchorSew™ 3 mm is a resorbable repair ... Medicine ArthroSew suturing device to attach soft tissue ... implanted into a prepared hole in the bone, ... soft tissue anchors are made of a resorbable ...
Sutureless Harpoon Tip...
Medicine Products: