FDA vs Ranbaxy
|Special on B2B||A Commercial Feature|
US court rejects Ranbaxy plea against US FDA
Ranbaxy had filed a lawsuit against US FDA for revoking tentative approvals granted to it for making generics of Valcyte and Nexium
According to a Reuters report, a US court has rejected Ranbaxy’s request to stop the launch of generics of heartburn pill, Nexium, and anti-viral, Valcyte. Ranbaxy had filed a lawsuit on November 11, 2014, in the District of Columbia in the US against the decision of US Food & Drug Administration (US FDA) to revoke approvals for the generic versions of Valcyte (marketed by Roche) and Nexium (marketed by Astrazenca).
Following this, Ranbaxy had approached the US court against US FDA for revoking tentative approvals granted to it for making generics of Valcyte and Nexium.
The latest verdict of the US court could have severe effect on Ranbaxy as some experts believe that loss of six-month exclusivity period for two drugs (Valcyte and Nexium) in the US market could cost Ranbaxy as much as $200 million in revenue.
According Reuters report, Endo had already launched its generic version of Valcyte, while Dr Reddy’s was expected to market the drug in the US very shortly.
Regulatory Action Against Ranbaxy
FDA Press Release: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert (9/16/2013)
FDA Form 483 (PDF – 2MB) (9/11/2012)
FDA Form 483 (PDF – 785KB) (12/7/2012)
Department of Justice Action Against Ranbaxy
- DOJ News Release: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, CGMP Violations and False Statements to the FDA (5/13/2013)
FDA News Release: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/25/2012)
FDA AIP Letter to Ranbaxy Laboratories (updated 3/2/2009)
FDA News Release: FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
- FDA News Release: FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (9/16/2008)
- List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd.
- Questions and Answers
- Warning Letter Dewas, India
- Warning Letter Batamandi (Unit II), in Paonta Sahib, India
Additional Warning Letters
FDA NEWS RELEASE
For Immediate Release: Jan. 23, 2014
Media Inquiries: Christopher Kelly, 301-796-4676, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market
Another Ranbaxy facility added to existing consent decree
The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
The decree contains, among other things, provisions to ensure compliance with current good manufacturing practice (CGMP) requirements at Ranbaxy facilities in Paonta Sahib and Dewas, India, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy’s Mohali facility to the CGMP provisions of the decree.
Under the decree, the FDA has issued an order prohibiting Ranbaxy from:
• distributing in the United States drugs manufactured using API from Toansa, including drugs made by Ranbaxy’s Ohm Laboratories facility in New Jersey;
• manufacturing API at its Toansa facility for FDA-regulated drug products;
• exporting API from Toansa to the United States for any purpose; and
• providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.
“We are taking swift action to prevent substandard quality products from reaching U.S. consumers,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that the drugs American consumers receive – no matter where they are produced – meet quality standards and are safe and effective.”
The FDA exercised its authority under a provision in the consent decree which permits the agency to extend the decree’s terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug, and Cosmetic Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality. The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree.
The FDA’s inspection of the Toansa facility, which concluded on Jan. 11, 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.
The agency is evaluating potential drug shortage issues that may result from this action. If the FDA determines that a medically necessary drug is in shortage or at risk of shortage, the FDA may modify this order to preserve patient access to drugs manufactured under controls that are sufficient to assure quality, safety and effectiveness.
As a result of this action, Ranbaxy is now prohibited from manufacturing API for FDA-regulated drugs at the Toansa facility and from introducing API from that facility into interstate commerce, including into the United States, until the firm’s methods and controls used to manufacture drugs at the Toansa facility are established, operated and administered in compliance with CGMP.
Ranbaxy is required to hire a third-party expert to thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with CGMP. Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility.
The FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Patients who are concerned about their medications should talk with their health care professional before discontinuing treatment.
For more information:
FDA Regulatory Activities for Ranbaxy Laboratories
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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