There comes a breather finally for Ranbaxy Laboratories as it attempts to touch the US market by launching the generic version of the world’s top-selling drug Lipitor.
Last year, there were sales of $7.27 billion in the US when it comes to Ranbaxy that is based in Gurgaon, which holds the first-to-file, FTF, status on Lipitor. The launch of the generic version of Lipitor, which is being treated as a drug to lower down cholesterol, was stopped following a lawsuit that was filed by US firm Mylan Labs that had put Lipitor was in an awkward situation.
If claims from Mylan are to be followed then due to Ranbaxy falsifying data from its Indian manufacturing plant where Lipitor’s filing was made, is ineligible for launching the generic version.
But it has been stated by the US Food and Drug Administration, FDA, that seeking action by Mylan is not right at this moment because no approvals for any of the applications filed for generic Lipitor has come from the regulatory body. Until an application is ready to get approved, nothing can be decided, according to the FDA.
