Navigation Links
FDA Halts New Applications From Indian Drug Maker's Plant
Date:2/25/2009

Agency says Ranbaxy Laboratories facility falsified scientific data

WEDNESDAY, Feb. 25 (HealthDay News) -- U.S. health officials have halted the review of any new drug applications from a Ranbaxy Laboratories plant in India after determining the facility was falsifying scientific data.

Ranbaxy, based in India, is one of the largest suppliers of generic drugs to the United States.

"We took this action after it became apparent that this facility was submitting falsified scientific data in applications for FDA approval of marketed drugs in the United States," Dr. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, said during a Wednesday teleconference.

Falsifying data in drug applications is a "serious breach of integrity -- a breach that must be quickly addressed and corrected," Throckmorton added.

Throckmorton noted this is the second action against the Paonta Sahib facility in less than six months. "No other Ranbaxy facilities are directly affected by this action," he said.

Until these problems are resolved, the FDA will stop review of drug applications from the Paonta Sahib plant and the agency will not accept any new applications from this plant, Throckmorton said.

These applications fall into three categories, drugs made in the plant for the U.S. market, drugs not marketed in the United States pending FDA approval, and drugs made in the United States that relied on data from the Paonta Sahib plant.

Last September, the FDA denied U.S. entry of 30 generic drugs made at the Paonta Sahib plant and a sister facility in Dewas, India, for problems related to the manufacturing process. At that time, FDA officials also recommended denying any new drug applications from those two plants.

Some of the false data supplied from the Paonta Sahib plant involved the shelf life of products, Deborah Autor, director of the FDA's Office of Com
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. Kellogg Halts Sales of Peanut Butter Crackers
2. Gastric Bypass Halts Diabetes in Obese Teens
3. PA Department of Health Halts Admissions at Commonwealth Medical Center in Beaver County
4. Surgical technique halts cell loss, Parkinsons researchers find
5. St. Jude finds signaling system that halts the growth of a childhood brain cancer
6. Manufacturer Halts Production of Blood Thinner Heparin
7. Experimental Vaccine Halts Prostate Cancer in Mice
8. Scripps research scientists find new genetic mutation that halts the development of lupus
9. Photo: New Data Show Gleevec(R) Halts Progression to Advanced Stages of Life-Threatening Form of Leukemia in Sixth Year of Treatment
10. Nephros Provides Update on 510k Applications
11. IMRIS announces development program for MR guided radiation and interventional applications
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Halts New Applications From Indian Drug Maker's Plant
(Date:8/21/2014)... environmental source of fungal infections that have been sickening ... grows on trees. , The discovery is based on ... the summer gathering soil and tree samples from areas ... fungus named Cryptococcus gattii (CRIP-to-cock-us GAT-ee-eye). ... of species including C. gattii , causes life-threatening ...
(Date:8/21/2014)... Black mothers are less likely than white moms to ... Hospitals in neighborhoods with many black residents do less ... white residents, a U.S. government study finds. Key ... medical centers where the black population is higher than ... and Prevention reported Thursday. These practices include efforts ...
(Date:8/21/2014)... Aug. 21, 2014 (HealthDay News) -- Among seniors, dimming ... The study involved more than 2,500 people, aged 65 ... study and again two, six and eight years later. ... the person,s risk of death during the study period, the ... effect, researchers led by Sharon Christ of Purdue University in ...
(Date:8/21/2014)... New York (PRWEB) August 21, 2014 ... against C.R. Bard, Inc. continue to move forward ... District Court, Southern District of West Virginia, Bernstein ... issued on August 14th, the Court has established ... that requires special handling, division, storage and preservation. ...
(Date:8/21/2014)... on her body in terms of how it can ... complete human being with thoughts and feelings. While objectification ... how does it affect individual romantic relationships? New research ... SAGE journal, finds that more objectification of a female ... pressure and coercion., Researchers Laura R. Ramsey and Tiffany ...
Breaking Medicine News(10 mins):Health News:Fungus deadly to AIDS patients found to grow on trees 2Health News:Racial Disparities in Breast-Feeding May Start With Hospitals, Study Suggests 2Health News:Failing Vision Tied to Shorter Lifespans for Seniors 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuits Move Forward in Federal C.R. Bard Litigation with Issuance of New Pretrial Order, Bernstein Liebhard LLP Reports 3Health News:Objectification in romantic relationships related to sexual pressure and coercion 2
... analyzing a sample of over 275,000 individuals, has found ... one size does not fit all. , Our study ... and if a person wants to be physically active, ... of Alberta. It is clear that different genders, ethnicities ...
... Day is a,time to celebrate healthy relationships and this ... Give Back A Smile,(GBAS) program celebrates that and so ... time and expertise pro bono to help,restore the smiles ... than 600 GBAS cases have been completed for a ...
... that exercise-trained mice get far fewer gallstones than sedentary ... occurs. , The study, recently published in the ... http://jap.physiology.org/cgi/reprint/01292.2007v1 . , For the first ... gallstone formation, adding to the ever-increasing number of reasons ...
... and Connects Physicians, ... Improves Quality Management, ... leading provider of clinical software, connectivity and,information solutions that ... has selected the Allscripts Electronic Health,Record (EHR) to connect ...
... has been awarded a $1.45 million five-year grant from ... factors that can minimize memory declines in middle-aged and ... behaviors that are tied to better memory and enhanced ... adults believe that memory declines are inevitable and there ...
... tracking the movement of,the prostate during radiation therapy ... Alliance. Featuring tiny GPS-type positioning transponders,implanted inside the ... in real time and alerts technicians if the ... the external beam of,radiation., The advantage of ...
Cached Medicine News:Health News:Study: When it comes to physical activity, one size does not fit all 2Health News:Caring Give Back A Smile Volunteer Dental Professionals Donate Over $5 Million in Services to Survivors of Domestic Violence 2Health News:U of I study: exercise to avoid gallstones! 2Health News:Mankato Clinic Selects Allscripts Electronic Health Record 2Health News:Mankato Clinic Selects Allscripts Electronic Health Record 3Health News:Mankato Clinic Selects Allscripts Electronic Health Record 4Health News:Brandeis researcher awarded grant to investigate memory and aging 2Health News:GPS for the Prostate: System Keeps Radiation Therapy on Target 2
(Date:8/21/2014)... , Aug. 21, 2014   Memorial Hermann Health ... Cancer Center today announced a new partnership to provide ... of community breast care centers in the greater ... MD Anderson will become the exclusive provider of professional breast ... centers, located in Memorial City, The Woodlands ...
(Date:8/21/2014)... , Aug. 21, 2014  Publicis Groupe customer ... , Managing Partner and Healthcare Industry Group Leader, has ... which recognizes the most inspiring people in the life-sciences ... in research and development, marketing, technology, creativity, strategy and ... 2006 as a partner in its leading Rosetta Consulting ...
(Date:8/21/2014)... , N.Y. and HAMBURG, Germany , Aug. ... it is collaborating with Deutsches Elektronen-Synchrotron ( DESY ), ... , to speed up management and storage of ... Data and Analytics architecture based on IBM software ... second of data at peak performance and help scientists ...
Breaking Medicine Technology:Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 2Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 3Memorial Hermann, MD Anderson join forces to provide enhanced breast imaging services throughout the Greater Houston Region 4Shannon Hartley Shines in PharmaVOICE 100 2DESY and IBM Develop Big Data Architecture for Science 2DESY and IBM Develop Big Data Architecture for Science 3
... HeartWare International, Inc. (NASDAQ: HTWR, ASX:HIN) has scheduled a ... three and 12 months ended December 31, 2011, at ... 16, 2012 (being midnight Australian Eastern Daylight Time, between ... to release the financial results prior to the conference ...
... 2012  After only three years in business, 89 North ... Society for Optics and Photonics (SPIE) on Jan. 25. ... of  "Life Sciences and Biophotonics." The new ... and exceptionally stable new light source used for quantitative ...
Cached Medicine Technology:HeartWare Schedules Fourth Quarter Conference Call and Webcast 289 North Wins Prestigious International Award 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: