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King Pharmaceuticals Receives Approval for Levoxyl NDA From FDA

Two Approved Levothyroxine Drugs Now Available

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Updated December 13, 2003

May 25, 2001 -- King Pharmaceuticals, Inc. has announced that they have received approval from the U.S. Food and Drug Administration (FDA) for a new drug application (NDA) for the Levoxyl brand of levothyroxine sodium tablets. The Levoxyl approval is the second approval of a Levothyroxine drug. The drug Unithroid was approved in August of 2000.

King's application was submitted on August 1, 2000, and the FDA's approval comes nine months after the company's initial submission.

Synthroid, which has been the top seller of thyroid hormone replacement, has not received FDA approval to date. Until recently, the manufacturer had been delaying applying to the FDA in the hopes that its petition for Generally Recognized as Safe and Effective (GRAS/E) status would be approved. [link url=http://thyroid.about.com/library/weekly/aa050301a.htm]The FDA's denial of that request, however, forced manufacturer Knoll Pharmaceucticals, a division of Abbott Labs, to announce last month that they would proceed with filing of an NDA. The typical NDA approval process takes around nine to ten months, so patients and practitioners concerned about what will happen to availability of Synthroid in August of 2001, when FDA regulations will call for any unapproved drugs to be pulled off the market. Synthroid is also [link url=http://thyroid.about.com/library/weekly/aa051401a.htm]under attack by the Gray Panthers, who are calling for Synthroid to be pulled from the market.

In a press release issued by the company, John M. Gregory, Chairman and Chief Executive Officer of King, stated, "We are very excited about the expeditious approval of King's new drug application for Levoxyl by the FDA. Likewise, we are extremely pleased with the sales growth of Levoxyl this year. I believe this approval is particularly significant in light of the maker of Synthoid's recent press release stating that they have yet to submit their application to the FDA."

According to Levoxyl's manufacturer, Levoxyl's net sales grew to $17.3 million in the first quarter of 2001, a 17% increase over the first quarter of 2000. King recently announced that it projects net sales of Levoxyl to exceed $20 million in the second quarter ending June 30, 2001.

It's possible that Levoxyl's price differential may be accounting for its increased sales. A Drugstore.com search on May 25, 2001 revealed that the cost of Unithroid is in many cases more than double the cost for Levoxyl.

Levoxyl
Levoxyl 88 MCG 30 tablets/$5.49 90 tablets/$12.12
Levoxyl 125 MCG 30 tablets/$5.49 90 tablets/$14.90
[link url=http://www.drugstore.com/pharmacy/drugIndex/rxSearch.asp?search=unithroid&searchtype=3" target="newframe]Unithroid
Unithroid 88 mcg 30 tablets/$9.34 90 tablets/$28.01
Unithroid 125 MG 30 tablets/$11.02 90 tablets/$33.06

Patients are also reporting difficulties obtaining Unithroid through various drugstores and chains, while Levoxyl is typically widely available at most pharmacies.

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