It's all fun and games until someone files an ANDA. In this case, Ranbaxy is the company, and the ANDA is for high-demand, high-profit-margin generic Lipitor.
The stakes are high for Ranbaxy. For the rest of the pharma industry, the message is clear: Take that warning letter seriously, provide a prompt and informed reply and follow through.
Fortune provides a rundown. In the normal course of events, Ranbaxy would soon begin enjoying its first-filer exclusivity of six months for the generic late this year. But the events course is abnormal. Going back to 2008, after repeat manufacturing violations and data irregularities, the FDA halted drug imports from two Ranbaxy plants, one of which is where the generic Lipitor will be made. And the FDA has prohibited the drugmaker from introducing new drugs from that plant to the U.S.
So the two years of plant inspection observations and "inadequate responses"--even after Ranbaxy came under the control of the respectable Daiichi Sankyo--have been followed by two years of attempted appeasement of the FDA. All seemingly to no avail, but Fortune hints that a deal perhaps in the 10-figures may be in the works. But for now, Ranbaxy is still unable to import generic Lipitor in November, as scheduled, until it gets the FDA's OK.
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