Pfizer May Get Generic Lipitor Delay |
| Bloomberg - Sep 2, 2011 |
Pfizer Inc. (PFE) may get a reprieve from generic competition to its $11 billion Lipitor cholesterol pill as Ranbaxy Laboratories Ltd. (RBXY) fights regulatory breaches that threaten to derail its push to produce the first U.S. copies.
Ranbaxy, India’s third-largest drugmaker by revenue, plans to introduce its copy of Lipitor, the world’s best-selling medicine, on Nov. 30. It must first persuade the Food and Drug Administration that its copy is equivalent to the original and that approval shouldn’t be thwarted by violations cited in 2009 at a plant identified in Ranbaxy’s drug application.
Failure to resolve the issue could prevent the FDA from clearing Ranbaxy’s Lipitor version by that date, said Ira Loss, an analyst with Washington Analysis. A delay also may stall plans by other generic-drug companies to introduce their versions of the $11 billion-a-year medicine, he said.
Read Full Article from Bloomberg
- Posted: 2011-09-02 11:35:21
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