Last week, Ranbaxy Laboratories surprised many pharma-watchers with an 11th-hour approval for its copycat version of the Pfizer ($PFE) blockbuster Lipitor. The company had been promising it would launch its atorvastatin generic on time, true. But Ranbaxy also faced continuing problems with the FDA--problems it had been trying to resolve for years.
Now, the company may be one step closer to a final settlement with the agency, The Economic Times reports. The Indian paper says Ranbaxy has appointed a senior executive in the U.S. specially tasked with keeping the company out of regulatory hot water. Putting Manjeet Bindra, Ranbaxy USA's VP of quality, in charge of "data reliability" and compliance answers the FDA's demands for a permanent regulatory point person, the paper says.
The Economic Times' sources say Bindra's appointment is one of several steps Ranbaxy has agreed to as part of a consent decree with the agency that is expected to be signed soon. The agreement will also include a penalty of $350 million to $400 million, the Times reports. And it would allow the company to resume selling some 30 products made in India that have been under an import alert since December 2008. Ranbaxy wouldn't comment about Bindra's appointment or on the possibility of a consent decree.
- read the Times story