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 Compliance at the Center for Drug Evaluation and Research, said during the teleconference. In addition, the company falsified data about production practices, she said.

The agency will begin reviewing applications only after Ranbaxy is able to prove to the agency that all of its data are correct and the FDA no longer has a concern about the data in the applications, Autor said.

While most products made by the company in the United States are not part of the FDA action, Autor added, there are some U.S. products that are affected.

Two of them are cholesterol-lowering drugs, pravastatin (Pravachol) and imvastatin (simvastatin), and an antihistamine known as pheniramine (Avil), Autor said.

The FDA is asking Ranbaxy for assurance that none of the data on these drug applications are from the Paonta Sahib facility, she explained.

Throckmorton was careful to say that the FDA has received no reports of harm caused by Ranbaxy products made in the United States or in the Paonta Sahib plant.

In addition, the agency is advising patients not to stop taking any medications without talking with their doctors first, he said.

More information

For more information on drug safety, visit the U.S. Food and Drug Administration .



SOURCES: Feb. 25, 2009, teleconference with: Douglas Throckmorton, M.D., deputy director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, FDA


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

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:6/27/2016)... , ... June 27, 2016 , ... TopConsumerReviews.com recently awarded ... Eyeglasses . , Millions of individuals in the United States and Canada wear ... a way to both correct vision and make a fashion statement. Even celebrities use ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe ... from the David Geffen School of Medicine at UCLA. He trained in Internal Medicine ... his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 ... Tomorrow,s Leaders Scholarship is any indication, the future is ... online at www.diabetesscholars.org by the Diabetes Scholars ... in the way of academic and community service excellence. ... program since 2012, and continues to advocate for people ...
Breaking Medicine Technology: