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New & Approved: Levoxyl * Campath.(for the treatment of hypothyroidism)

Internal Medicine News

| July 15, 2001 | Mechcatie, Elizabeth | COPYRIGHT 2001 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Levoxyl

(levothyroxine sodium, King Pharmaceuticals)

A synthetic thyroid hormone for treating hypothyroidism and suppressing thyroid-stimulating hormone. This is the second thyroid hormone product approved by the Food and Drug Administration under a 1997 requirement that manufacturers of all marketed levothyroxine products file new drug applications by Aug. 14, 2001, These products were available before 1962, so they were never formally approved and did not undergo a full review.

* Recommended Dosage: Available in tablets ranging in strength from 25 [mirco]g to 300 [mirco]g.

* Special Considerations: Side effects of levothyroxine "are usually due to over-dosage and include, nervousness, weight loss, tachycardia, irritability, and anxiety," the FDA stated in August 2000 in approving Unithroid, the first such product approved under the new requirements.

* Comment: The approval establishes that the FDA considers Levoxyl effective and in compliance with standards for manufacturing, purity, potency and stability. Product recalls related to problems with stability and potency led to the 1997 FDA requirement. The products of companies that fail to meet the Aug. 15 deadline will be "subject to regulatory action as an unapproved drug," according to the FDA.

More than 70 million prescriptions for synthetic thyroid replacement drugs were dispensed last year, making such drugs the eighth most commonly dispensed prescription drug category in 2000, according to IMS America, a pharmaceutical market research firm. More than 60% of those prescriptions were for Synthroid, the third most commonly dispensed drug in 2000.

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