FDA Approves Generic Lipitor; Will Be Marketed By Ranbaxy
November 30 2011 - 7:46PM
Dow Jones News
The U.S. Food and Drug Administration Wednesday approved the
first generic version of Pfizer Inc.'s (PFE) cholesterol-lowering
drug Lipitor.
Earlier Wednesday Watson Pharmaceuticals Inc. (WPI) began
selling a generic version of Lipitor, marking the long-awaited loss
of U.S. market exclusivity for the world's top-selling drug.
Watson, of Parsippany, N.J., is selling a so-called authorized
generic version of Lipitor, in partnership with Pfizer. The deal
runs until November 2016.
The agency said Ranbaxy Laboratories Ltd., a unit of Japan's
Daiichi Sankyo Co., (4568.TO) gained approval to make generic
atorvastatin calcium tablets in four strengths ranging from 10 to
80 milligrams.
FDA said the drug will be manufactured by Ohm Laboratories in
New Brunswick, N.J.
Under the federal law authorizing generic drugs, Ranbaxy was
given first dibs on selling a no-name version of Lipitor for 180
days because it was the first to apply for FDA approval, submitting
a request in 2002.
In 2008, Ranbaxy reached agreement with Pfizer allowing for
sales to start Nov. 30. Yet it was unclear whether the FDA would
grant approval, given the manufacturing problems the agency had
found at the company. The FDA accused a Ranbaxy plant in India of
submitting false and unreliable data.
Cholesterol-lowering drugs like Lipitor work to lower
low-density lipoprotein, or LDL, cholesterol often referred to as
"bad" cholesterol. High cholesterol increases the likelihood of
developing heart disease and other cardiovascular-related
conditions.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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