Claris CEO says FDA woes nearing end

Claris Lifesciences is getting closer to getting back in the FDA's good graces. CEO Arjun Handa says that the company has tapped an external consultant for quality-control advice, Dow Jones reports. Plus, the company is adding new manufacturing checks and controls, aiming to resolve its regulatory differences and get all its products back on the U.S. market.

Claris has been under an import ban from the FDA since November 2010. The agency imposed the restrictions after finding multiple manufacturing violations at its plant in India, and the company has been working to resolve those issues by buying new machines, installing new technology, and taking other steps to make sure the problems don't recur, Handa says.

It's probably no consolation to Claris or its investors, but the company obviously isn't alone in its long-running import ban. Fellow Indian drugmaker Ranbaxy Laboratories is still working on resolving problems with the FDA that began in September 2008--problems that might just interfere with its ability to take advantage of first-to-market exclusivity on potentially the biggest generic drug in history, copycat Lipitor.

- get the story from Dow Jones

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