Navigation Links
FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
Date:12/1/2008

- First Local Estrogen Therapy Indicated for the Treatment of Both Moderate to Severe Vaginal Dryness and Pain With Intercourse - Symptoms of Vulvar and Vaginal Atrophy Due to Menopause

- Further Expands Company's Hormone Therapy Product Line

MONTVALE, N.J., Dec. 1 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream. SCE-A Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause. It is administered intravaginally at a dose of 1 gram daily for one week, followed by 1 gram intravaginally twice a week.

SCE-A Vaginal Cream will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in the second quarter of 2009 utilizing direct sales force activities as well as other indirect marketing initiatives.

"SCE-A Vaginal Cream offers an additional treatment option to women and healthcare professionals," said Fred Wilkinson, Duramed's Chief Executive Officer. "With its unique indication and dosing regimen, it is designed to complement our existing line of plant-derived estrogen therapies for the treatment of post-menopausal symptoms."

According to the North American Menopause Society (NAMS), an estimated 10 to 40 percent of post-menopausal women suffer from symptoms related to vaginal atrophy(1). Two of the most common symptoms of vaginal atrophy are vaginal dryness and pain with in
'/>"/>

SOURCE Barr Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine news :

1. FDA Approves First Anti-Psychotic for Kids
2. FDA Approves New Roche West Nile Virus Blood Screening Test
3. FDA Approves Osteoporosis Drug to Cut Breast Cancer Risk
4. FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis
5. FDA Approves SOMA(R) (carisoprodol) 250 mg
6. FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
7. FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr
8. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
9. ABIH Approves Certification Credit for SSPC Training Courses
10. FDA Approves REALIZE(TM) Adjustable Gastric Band for Morbid Obesity
11. FDA Approves New Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... ... August 28, 2015 , ... ... Devices:, Understanding the FDA’s Position and Best Practices for Compliance, **Presented by ... , This workshop, chaired by internationally renowned expert Fubin Wu, has been ...
(Date:8/28/2015)... ... August 28, 2015 , ... The 6th Annual Survivor in ... Foundation has added yet another accolade to its cadre of widespread support—an official letter ... “With the help of the medical community and the University of Illinois at Chicago’s ...
(Date:8/28/2015)... ... August 28, 2015 , ... Loved ... might personally be struggling with chemical dependency, may be able to find some ... a results-driven holistic treatment center for addiction located in Western Michigan. Focusing on ...
(Date:8/28/2015)... ... 2015 , ... “ Frequentz ” was featured on NewsWatch as part of ... the market for iOS, Android, and Windows. Joe Toohey, the host of AppWatch and ... businesses to track product movement from beginning to end. , Businesses benefit greatly from ...
(Date:8/28/2015)... ... August 28, 2015 , ... Drugs and alcohol abuse by ... a new approach on solutions in his new book ":Unraveling The Psychological Mystery ... getting together for meaningful group meetings. "This would educate the employees on not ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 2Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 3Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 4Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 5Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 2Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 3Health News:Best Drug Rehabilitation Releases New Video Outlining Patients' Personal Recovery Stories 2Health News:Best Drug Rehabilitation Releases New Video Outlining Patients' Personal Recovery Stories 3Health News:Track Product Movement from Beginning to End with Frequentz 2
... of stroke and coronary heart disease in young women ... the same operation. This fact provides the background for ... hysterectomy rates in Germany, which appears in the current ... Int 2011; 108[30]: 508-14). Removal of the ...
... Reporter , WEDNESDAY, Aug. 10 (HealthDay News) -- Women who ... disease than male smokers do, according to a huge, new ... known, researchers suspect there are biological differences in how women,s ... absorb more carcinogens and other toxic agents in cigarettes compared ...
... (Edmonton, Canada) Access to health care and the usage of ... Jones, a graduate student in the University of Alberta,s School ... School of Public Health, and Leonard Frank, executive director of ... study that examined whether or not there was a clear ...
... HealthDay Reporter , WEDNESDAY, Aug. 10 (HealthDay News) -- ... possible outbreaks of the tick-borne illness in humans, government researchers ... they can be a good indicator of the risk of ... Control and Prevention said. When blood tests show that few ...
... , WEDNESDAY, Aug. 10 (HealthDay News) -- ... to adults about their fitness progress helps them stick ... University of Pittsburgh researchers followed 189 overweight adults for ... three self-monitoring programs -- paper records only, PDA without ...
... by University at Buffalo sociologists has found that the portrayal ... decades has become increasingly sexualized, even "pornified." The same ... findings may be cause for concern, the researchers say, because ... far-reaching negative consequences for both men and women. ...
Cached Medicine News:Health News:Women May Face Greater Heart Risk From Smoking Than Men 2Health News:Women May Face Greater Heart Risk From Smoking Than Men 3Health News:After-hours care affects emergency department use in Leduc 2Health News:Tracking Lyme Disease in Dogs May Help Protect Humans 2Health News:Tracking Lyme Disease in Dogs May Help Protect Humans 3Health News:Study finds marked rise in intensely sexualized images of women, not men 2Health News:Study finds marked rise in intensely sexualized images of women, not men 3
(Date:8/27/2015)... 27, 2015  Now that Intuitive Surgical, Inc.® has ... surgical robot, hospitals with robotic surgery programs need to ... to see where they stand with robotic surgery. Are ... Have they adopted best practices for safety? Should they ... future? ECRI Institute, which has nearly 50 ...
(Date:8/27/2015)... , Aug. 27, 2015   ... Pharmacy Provider (IOPP™) is expanding its population ... a medication-focused transition of care program for ... "RxCare Management," provides hospitals with technology systems ... performance measures that have been mandated by ...
(Date:8/27/2015)... LAKEWOOD, Ohio , Aug. 27, 2015  A ... according to Booz Allen Hamilton . A ... that product development inefficiencies are impeding and disrupting manufacturers, ... Can Cut Waste and Improve Value In Product Development ... cost of inaccessible data and how it affects the ...
Breaking Medicine Technology:ECRI Institute's New Robotic Surgery Service Helps Hospitals Brace for Change 2ECRI Institute's New Robotic Surgery Service Helps Hospitals Brace for Change 3Rx Care Management by Proxsys Rx - Transition of Care Technology Helps Prevent Hospital Medication Errors 2New White Paper Reveals How Manufacturers Can Improve Product Development Processes 2
... , Feb. 17 New research ... Parkinson,s disease, according to a study released today that will be presented ... Toronto April 10 to April 17, 2010 . , ... the beginning of the research.  Participants were asked about their use of ...
... Italy , Feb. 17 The results of ... EVEREST (European Vertebroplasty Research Team) Centers (Dr. G.C. Anselmetti-Candiolo Torino, ... S. Masala-Roma , Dr. M. Muto-Napoli ,) confirms the ... that the procedure provides significant and sustained pain relief. , ...
Cached Medicine Technology:An Ibuprofen a Day Could Keep Parkinson's Disease Away 2Multi-Center Data in a Large Series of Patients Show Vertebroplasty Provides Dramatic and Lasting Pain Relief for Vertebral Compression Fractures 2Multi-Center Data in a Large Series of Patients Show Vertebroplasty Provides Dramatic and Lasting Pain Relief for Vertebral Compression Fractures 3Multi-Center Data in a Large Series of Patients Show Vertebroplasty Provides Dramatic and Lasting Pain Relief for Vertebral Compression Fractures 4
... is a freestanding cryostat with a ... and a radial cutting microtome. It ... wide range of specimens and materials ... in high biohazard risk laboratories where ...
The HM 550 series is a uniquely progressive concept for use with frozen specimens of all types. User applications define module selection and make even serial sectioning enjoyable....
... TP1020 product family are semi-enclosed tissue processors. ... of approved technology with modern and functionally ... safety for tissues at all stages of ... on proven precision mechanics in conjunction with ...
The HMP300 Histo Pro delivers all the features and benefits that conventional tissue processing have to offer....
Medicine Products: