PITTSBURGH, Feb. 8 Mylan Inc. (NYSE: MYL) todayannounced that Mylan Pharmaceuticals Inc. has obtained an order from anadministrative law judge in Florida finding that the inclusion ofLevothyroxine Sodium on the state's negative drug formulary is an invalidexercise of legislative authority and that the product should be removed fromthe negative formulary.
Mylan will make its products available to pharmacies in Florida as soon asmotions and procedural steps surrounding its removal from the negativeformulary are satisfied. Florida's Board of Medicine and Board of Pharmacyvoted not to appeal the Jan. 28, 2008, order; Abbott Laboratories has filed aformal appeal.
When a drug is included on Florida's negative formulary, pharmacistscannot substitute a generic version for a prescribed brand version. Floridapharmacists have been prohibited from substituting the generic version ofLevothyroxine Sodium, depriving patients access to an affordable, effectiveand safe generic approved by the U.S. Food and Drug Administration.
In August 2007, Mylan filed a petition against Florida's Department ofHealth, Board of Pharmacy and Board of Medicine challenging the validity ofLevothyroxine's inclusion on the negative formulary. Abbott Laboratories,maker of a brand version of Levothyroxine Sodium (Synthroid(R)), intervened.In an order issued Jan. 28, Mylan's subsequent motion for summary final orderwas granted.
"This ruling is not just a victory for Mylan, it's a major victory for thecitizens of Florida who have been denied access to lower cost LevothyroxineSodium for years," said Mylan's Chief Operating Officer Heather Bresch. "Thestate will benefit from tens of millions of dollars in savings as a result ofthis decision, and we are extremely pleased that the judge on this case sawthrough the brand company's baseless tactics to limit consumer access toaffordable and effective medications."
Levothyroxine Sodium is indicated for the treatment of hypothyroidism andpituitary TSH suppression. According to IMS Health, more prescriptions arefilled nationwide with Mylan's Levothyroxine Sodium tablets than any otherLevothyroxine product, brand or generic. Mylan's version is the only genericproduct considered therapeutically equivalent to four brand versions,including Synthroid(R), Levoxyl(R), Levothroid(R) and Unithroid(R).
Mylan Inc. is one of the world's leading quality generic and specialtypharmaceutical companies. The Company offers one of the industry's broadestand highest quality product portfolios, a robust product pipeline and a globalcommercial footprint through operations in more than 90 countries. Through itscontrolling interest in Matrix Laboratories Limited, Mylan has direct accessto one of the largest active pharmaceutical ingredient (API) manufacturers inthe world. Dey, L.P., Mylan's fully integrated specialty business, providesthe Company with innovative and diversified opportunities in the respiratoryand allergy therapeutic areas. For more information about Mylan, please visitwww.mylan.com.
SOURCE Mylan Inc.