Call Us: 1.800.873.5297

By

Ranbaxy Files Corrective Action Plan with FDA

Recently on May 18, Generic drug maker Ranbaxy Laboratories filed a corrective action plan to take steps to rectify the current FDA ban on some of its generic drugs and allegations falsifying new drug applications. In September of 2008, the FDA barred some of Ranbaxy’s drugs from import to the U.S because of violations found during inspections of the Dewas and Paonta Sahib Facilities in India. The Paonta Sahib plant was cited in February of 2009 for falsifying data on new and approved drug applications.

While the details of the corrective plan have not been released, “The FDA is working very closely with the firm to ensure that all the Ranbaxy products currently in the U.S. market are safe and effective,” FDA spokesman Christopher Kelly said in an e-mail to Bloomberg.com yesterday. “The next steps will be dependent on the actions identified” in the plan, he said. A corrective plan of action includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.

Based in India and operating in the United States since 1995, Ranbaxy is one of the 10 largest generic-drug producers in the world. Several scandals have surround Ranbaxy this past year. In July of 2008, US prosecutors alleged that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the United States. Allegations included that Ranbaxy concealed violations of good manufacturing practice regulations from FDA and made weak or adulterated HIV drugs dispensed in Africa.

 


In February the FDA also said the plant in Paonta Sahib falsified data and test results in approved and pending drug applications. An inspection in 2006 revealed the problem which included incorrectly storing drug samples in refrigerators though stability testing required the drugs be stored at room temperature. Logbooks even did not identify which samples were in the refrigerator or how long they had been there.

To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.

 

The FDA halted the review of drug applications made at Ranbaxy’s Paonta Sahib plant in India because of the issue. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

 

The affected applications are for drugs that fall into three categories:

 

  • Approved drugs made at the Paonta Sahib site for theU.S. market; 
  • Drugs pending approval at the FDA that are not yet marketed; and 
  • Certain drugs manufactured in theUnited States that relied on data from the Paonta Sahib facility. 

In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

 

For more information:

 

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.