Does the FDA's blessing of a new generic drug from Ranbaxy Laboratories hint that the company's regulatory troubles may be nearing an end? Some Indian analysts are reading the agency's approval of copycat Aricept, the Eisai Alzheimer's drug, as an indication of better relations between U.S. regulators and the India-based company, which has faced an import ban on 30 of its products for two years now.
Ranbaxy got into hot water with the FDA back in 2008, when agency inspections turned up a number of serious problems. The FDA seized 30 of the company's products, banned importation of any medicine made at two Indian plants, and cut off potential approvals of new meds to be produced there.
Since then, the company--majority owned by Japan's Daiichi Sankyo--has been working to solve the plant's problems and negotiating with FDA on a solution. Executives have repeatedly promised an accord would come soon. They're saying the same thing now, according to local media reports. But this time may be different, given that FDA has actually given its blessing to a new Ranbaxy product; recently, the agency nixed its highly anticipated copycat version of the prostate drug Flomax. "It looks like things are moving in a very positive direction," PharmaAsia News' Vikas Dandekar told an Indian news network.
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