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Abbott Sues Watson Pharmaceuticals

June 12, 2001

CHICAGO (AP) _ Abbott Laboratories accused Watson Pharmaceuticals in a lawsuit filed Tuesday of making false advertising claims about Abbott’s prescription drug Synthroid, the nation’s top thyroid medication.

The U.S. District Court lawsuit comes as Synthroid faces an Aug. 14 deadline to get government approval, along with other thryoid-replacement drugs containing the chemical levothyroxine sodium.

Nearly 8 million people take Synthroid, the nation’s third-leading prescription drug, every day.

The legal dispute relates to the FDA’s recent rejection of an attempt by Synthroid maker Knoll Pharmaceutical, which Abbott acquired this year, to have the drug granted the status of ``generally regarded as safe and effective.″

Abbott is preparing a new application, but approval can take 10 months or more. It can still be prescribed during the review process.

The FDA, which in 1997 required the makers of drugs containing levothyroxine sodium to prove the safety and effectiveness, says Synthroid has changed its formula in the 46 years it has been on the market. It also has been investigating reports of problems with the drug’s potency.

Abbott is seeking a federal court injunction to stop Corona, Calif.-based Watson Pharmaceuticals, the maker of competing thyroid medication Unithroid, from issuing what it says is deliberate misinformation about the FDA approval process for Synthroid.

North Chicago, Ill.-based Abbott has received thousands of phone calls from concerned physicians, patients and pharmacists as a result of Watson’s claims in sales calls, spokeswoman Melissa Brotz said.

``Synthroid has been used safely and effectively by millions of patients for decades and it is false and misleading for Watson to claim otherwise,″ Abbott vice president David Pizzuti said in a news release. ``Worse are Watson’s false assertions that Synthroid will be unavailable in the near future to the millions of patients who depend on it.″

Experts have said the popular drug is extremely unlikely to be pulled off the market pending an application review.

Watson Pharmaceuticals spokesman Rob Funsten said he hadn’t seen Abbott’s suit but that the allegations cited in their statement are ``totally without merit.″

The lawsuit was announced after markets closed. Watson shares closed down 11 cents at $61.65 on the New York Stock Exchange while Abbott shares rose 33 cents to $50.72.

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On the Net:

Abbott site: http://www.abbott.com

Watson: www.watsonpharm.com