Navigation Links
FDA Advisory Committee Declines to Recommend Approval of Progesterone Vaginal Gel 8% for the Reduction of Risk of Preterm Birth in Women with Short Uterine Cervical Length
Date:1/20/2012

demonstrated ability to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy, would represent a significant advance in the prevention of early preterm birth and its associated complications."

The Committee evaluated data submitted by Columbia to the FDA in its New Drug Application (NDA 22-139), which includes data from two Phase III clinical trials.  One of these trials, the PREGNANT study, showed that women with a short uterine cervical length as measured by transvaginal ultrasound between 19 and <24 weeks of gestation who were treated with progesterone vaginal gel 8% had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who were treated with placebo (p=0.022). This study included women with and without a prior history of preterm birth.  Progesterone vaginal gel 8% was also associated with a significant reduction in the risk of preterm birth before 35 weeks gestation (p=0.012).

In the PREGNANT study, the frequency of maternal treatment-emergent adverse events both overall and by individual event was comparable between the placebo and progesterone vaginal gel treatment groups. The most frequent events in the progesterone vaginal gel group were expected complications of a high-risk pregnancy and included "premature baby" (19%), "uterine contractions abnormal" (14%), "premature labor" (7%). "Cervical disorder" (10%), "nausea" (10%), "headache" (7%), and "vulvo vaginal mycotic infection" (7%) were also reported.

The Advisory Committee for Reproductive Health Drugs is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of reproductive conditions and makes non-binding recommendations to the FDA.  

About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company i
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Sutro Announces Newly Formed Scientific Advisory Board
2. FDAs Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012
3. DiaTech Life Sciences Announces Medical Advisory Board
4. GenturaDx Announces Formation of Scientific Advisory Board
5. Saladax Biomedical, Inc. Appoints Li Zhang, M.D., to Scientific Advisory Board
6. Advanced BioMedical Technologies Inc. Announces Formation of Scientific Advisory Board
7. CBI Announces 3rd Effective Preparation for FDA Advisory Committees
8. NuMe Health Advances its Cobiotics™ Technology With Addition of Scientific Advisory Board and Filing of Patent Application for First Product
9. Exosome Diagnostics Announces Additions to Management and Scientific Advisory Board as Company Expands Clinical Validation Studies in Oncology
10. Jeunesse Global Announces New Medical Advisory Board Member and Admittance Into the Direct Selling Association (DSA).
11. FDA Advisory Panel Unanimously Recommends Approval of EXCOR(R) Pediatric Ventricular Assist Device for Use in the United States
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... , Aug. 27, 2015 /PRNewswire/ - Portage Biotech ... PBT.U), and Biohaven Pharmaceutical Holding Company Limited (Biohaven), ... Phase I study of BHV-0223, a glutamate modulating ... regarding BHV-0223 and recently obtained clearance from the ... with human testing. Portage holds 54% equity interest ...
(Date:8/27/2015)... YORK , August 27, 2015 ... enhancing image processing functions in the human vision system, announced ... point guard Chris Paul to develop ... players who want to improve their real-life on-court performance. ... the court, whether it is shooting a ball or blocking ...
(Date:8/26/2015)... Manhattan, KS (PRWEB) , ... August 26, 2015 ... ... & Biologic Solutions, announces today that a second US laboratory is to open ... in accordance with the continued partnership and long-term growth of research and development ...
(Date:8/26/2015)... FRANCISCO , Aug. 26, 2015  Platform ... that it has received a $1.5M Phase II ... (NIH) to further develop its therapeutic agent to ... clinical need in end stage renal disease (ESRD) ... the National Institute of Diabetes and Digestive and ...
Breaking Biology Technology:Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 2Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 3Portage's Biohaven doses first human subject in Phase 1 trial with lead drug candidate BHV-0223 4Eight-Time All-Star Chris Paul and GlassesOff Partner to Develop Innovative Mobile App Designed to Improve On-Court Performance 2Eight-Time All-Star Chris Paul and GlassesOff Partner to Develop Innovative Mobile App Designed to Improve On-Court Performance 3MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 3Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 2Symic Biomedical Awarded $1.5MM NIH Phase II SBIR Grant to Develop its Proteoglycan Mimetic Therapeutics to Reduce Vascular Access Failures in ESRD 3
... 19, 2010 Amsterdam Molecular,Therapeutics (EuroNext Amsterdam: AMT), a leader ... update in compliance with,the EU transparency directive. This report summarizes material ... , Q1 2010 Highlights, - ... Dossier validated by EMA on January 20, 2010, ...
... MOUNTAIN VIEW, Calif. , May 19 ... Schall , Ph.D., the Company,s President and Chief Executive ... Entrepreneur Of The Year® 2010 Award in Northern ... awards program recognizes entrepreneurs who demonstrate extraordinary success in ...
... , May 19 Hothead Technologies, Inc. ... the Sivix key computing fob and associated sensor monitoring ... These solutions are based upon the H.O.T.™ System, a ... the helmet of an athlete, firefighter, soldier, or other ...
Cached Biology Technology:AMT Provides Business Update for the First Quarter 2010 2AMT Provides Business Update for the First Quarter 2010 3ChemoCentryx President and CEO, Thomas J. Schall, Ph.D., Named Ernst & Young Entrepreneur Of The Year 2010 Award Finalist in Northern California 2ChemoCentryx President and CEO, Thomas J. Schall, Ph.D., Named Ernst & Young Entrepreneur Of The Year 2010 Award Finalist in Northern California 3ChemoCentryx President and CEO, Thomas J. Schall, Ph.D., Named Ernst & Young Entrepreneur Of The Year 2010 Award Finalist in Northern California 4Hothead Technologies Partners with Sivix Logistics to Add Customized Handheld Monitors and Autonomous Sensors to its Product Line 2Hothead Technologies Partners with Sivix Logistics to Add Customized Handheld Monitors and Autonomous Sensors to its Product Line 3
(Date:7/31/2015)... 31. juli 2015 Den 10. internationale konference ... BGI fra den 22. - 25. oktober i ... sin 10-års fødselsdag i år. Siden starten i 2006 ... møder på ,omik,-feltet, og er en af de mest ... ICG-10 fokuserer på nylige gennembrud og fremskridt inden for ...
(Date:7/31/2015)... de 2015 La 10 th International Conference ... de BGI del 22 al 25 de octubre de 2015 en ... año, la conferencia celebra su décimo aniversario. Desde su inauguración ... de las reuniones anuales más influyentes del mundo en el ... dinámicas, entusiastas y mejores a nivel científico. ...
(Date:7/30/2015)... July 30, 2015 Cellecta, Inc., a ... function analysis and biomarker discovery, announced the release ... Library targeting all human protein coding genes. CRISPR ... out" a gene,s function. Cellecta,s new Human Whole ... screening tool so that researchers can investigate in ...
Breaking Biology News(10 mins):Den 10. internationale konference om Genomics (ICG-10) åbner i oktober 2La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 2La 10th International Conference on Genomics (ICG-10) se llevará a cabo en octubre 3CELLECTA, INC. Announces Launch of Human Whole Genome CRISPR Knockout Library 2
... The 2010 Annual Meeting & OTO EXPO of the ... (AAO-HNSF), the largest meeting of ear, nose, and throat doctors ... MA. , Featuring more than 305 scientific research sessions, ... the annual meeting is a unique opportunity for journalists from ...
... paper published this week in the Proceedings of ... ecologist Dr. Emma Rosi-Marshall and colleagues report that streams ... that originate from adjacent genetically modified crops. The protein ... and plant parts are washed into stream channels. ...
... has received a $15 million grant from the National ... Research Excellence, or INBRE, program. The grant is centered ... the Department of Biological Science in the LSU College ... to strengthen the biomedical research infrastructure and work force ...
Cached Biology News:2010 AAO-HNSF new research highlights: Tuesday, Sept. 28, 2010 22010 AAO-HNSF new research highlights: Tuesday, Sept. 28, 2010 32010 AAO-HNSF new research highlights: Tuesday, Sept. 28, 2010 42010 AAO-HNSF new research highlights: Tuesday, Sept. 28, 2010 5Insecticides from genetically modified corn present in adjacent streams 2LSU receives $15 million grant from NIH to build biomedical research pipeline for Louisiana 2
The large Dodeca stainer shaking rack holds the staining trays in the large Dodeca stainer....
...
...
... Quansys Biosciences Q-Plex Array is a new ... human, mouse, and rat research. The Q-Plex ... ELISA-based test where 4 distinct capture antibodies ... a 96-well plate in a defined array. ...
Biology Products: