The US FDA has withdrawn approval of 27 ANDAs held by Ranbaxy Laboratories, a subsidiary of Daiichi Sankyo Co, Japan with effect from September 21, 2012 on account of the request of Ranbaxy for removal of application. At present, the company is not marketing these products which mainly includes cefaclor, cefadroxil dispermox, panixine, ramipril capsules, metformin HCI, pravastatin sodium tablets, etc. for treatment of high blood pressure, diabetes and others.
Ranbaxy has also waived its opportunity for a hearing. It requested withdrawal of approval under a Consent Decree of Permanent Injunction Decree of Permanent Injunction (Decree) entered in US, versus Ranbaxy during January 2012. The Decree specifies that Ranabxy must never submit another application to FDA for these withdrawn drug products and must never transfer these ANDAs to a third party.
Ranbaxy has clarified that the company has determined that certain products with negligible commercial impact should be withdrawn to enable the organization to focus resources on other applications that are of greater importance and value to the US business and healthcare system. Further, the aforesaid ANDAs do not pertain to current business and will have a negligible impact on the company’s business in USA.