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June 1, 2001 - FDA Could Make Abbott Pull Popular Thyroid Drug From The Market

June 1, 2001 - FDA Could Make Abbott Pull Popular Thyroid Drug From The Market

According to the Food and Drug Administration, Synthroid, known generically as levothyroxine sodium and given to patients who have hypothyroidism or other disorders of the thyroid, has to get the agency's approval or go off the market. Although the popular drug has been prescribed for more than 40 years, it has never been formally approved by the FDA. Recently, the agency concluded that the medicine has a "history of problems" and cannot be recognized as "safe and effective."

Thus, Abbott Laboratories, a company that acquired Synthroid's maker earlier this year, must submit its application to the agency by Aug. 14th, or the drug might not be allowed to stay on the market. Abbott maintains that the drug is safe and effective and should remain on the market. An Abbott spokeswoman said that during the two most recent inspections of its Synthroid plant, the FDA found no violations in its manufacturing processes, and that the product has a four-decade track record with millions of patients using it. The company representative also said that they will submit its application to the FDA "shortly."

The FDA official said the regulatory notices the agency has published on Synthroid and its competitors don't include a provision related to simply submitting an application by Aug. 14. The agency has not decided what it would do if the Aug. 14 deadline came and went before the drug received approval. But it would not rule out asking for the drug's removal and noted that there are two other approved drugs in Synthroid's class that could fill any void left by Synthroid.

Jane Axelrad, an FDA official, did note that "even if we were to decide it is appropriate to remove Synthroid from the market, it would take time for the patients to go to their doctors" and get prescriptions for new medications. "You can't just snap your fingers and take all Synthroid from the market on Aug. 15th." The agency based its decision on the fact that "almost every manufacturer" of such drugs had reported recalls because of potency problems.

In 1997, the FDA notified makers of levothyroxine sodium that it was going to regulate the drug and that makers would have to submit so-called "new drug applications" establishing their drugs' safety and efficacy. In April 2000, the FDA extended the deadline for such approval to Aug. 14, 2001. The FDA noted that companies "may continue to market their products until Aug. 14" and that makers who marketed their drugs "without an approved application after that date would be subject to regulatory action."

Synthroid is not the only drug that now has to receive a formal FDA approval. Two other drugs - Levoxyl from King Pharmaceuticals Inc. and Unithroid from Watson Pharmaceuticals Inc. and Jerome Stevens Pharmaceuticals Inc. - have applied for and received approval from the FDA. "We understood that we had to have an approval by Aug. 14, 2001, and we still understand that to be the case," said James Green, a spokesman for King. "Of course, we are approved now. We take comfort in that."

Mr. Green said that it took about 10 months for the FDA to approve King's application, and that the company is now "preparing for the possibility" that it will have to fill a void in the market in August. Mr. Green estimated that Synthroid holds 60% of the U.S. market for levothyroxine sodium, while King's Levoxyl has 25%.

If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.

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