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NEW YORK — While Indian generic drug maker Ranbaxy Labs is expected by many to launch a generic version of a cholesterol drug made by Pfizer later this year, it may have to sell its rights to it if it can't win Food and Drug Administration approval in time, according to published reports.
Citing Credit Suisse analysts, Bloomberg reported that the FDA may delay approval of Ranbaxy's version of Lipitor (atorvastatin), which would prevent it from marketing the drug starting Nov. 30, as it has planned to do.
Still, according to Bloomberg, the company — mostly owned by Japan's Daiichi Sankyo — is in discussions with the FDA.
Lipitor is the world's top-selling drug, with more than $7 billion in sales in the United States, according to IMS Health data.