Healthcare Industry News: Levothyroxine
News Release - February 8, 2008
Mylan Restores Availability of Generic Levothyroxine in FloridaPITTSBURGH, Feb. 8 (HSMN NewsFeed) -- Mylan Inc. (NYSE: MYL ) today announced that Mylan Pharmaceuticals Inc. has obtained an order from an administrative law judge in Florida finding that the inclusion of Levothyroxine Sodium on the state's negative drug formulary is an invalid exercise of legislative authority and that the product should be removed from the negative formulary.
Mylan will make its products available to pharmacies in Florida as soon as motions and procedural steps surrounding its removal from the negative formulary are satisfied. Florida's Board of Medicine and Board of Pharmacy voted not to appeal the Jan. 28, 2008, order; Abbott Laboratories has filed a formal appeal.
When a drug is included on Florida's negative formulary, pharmacists cannot substitute a generic version for a prescribed brand version. Florida pharmacists have been prohibited from substituting the generic version of Levothyroxine Sodium, depriving patients access to an affordable, effective and safe generic approved by the U.S. Food and Drug Administration.
In August 2007, Mylan filed a petition against Florida's Department of Health, Board of Pharmacy and Board of Medicine challenging the validity of Levothyroxine's inclusion on the negative formulary. Abbott Laboratories, maker of a brand version of Levothyroxine Sodium (Synthroid®), intervened. In an order issued Jan. 28, Mylan's subsequent motion for summary final order was granted.
"This ruling is not just a victory for Mylan, it's a major victory for the citizens of Florida who have been denied access to lower cost Levothyroxine Sodium for years," said Mylan's Chief Operating Officer Heather Bresch. "The state will benefit from tens of millions of dollars in savings as a result of this decision, and we are extremely pleased that the judge on this case saw through the brand company's baseless tactics to limit consumer access to affordable and effective medications."
Levothyroxine Sodium is indicated for the treatment of hypothyroidism and pituitary TSH suppression. According to IMS Health, more prescriptions are filled nationwide with Mylan's Levothyroxine Sodium tablets than any other Levothyroxine product, brand or generic. Mylan's version is the only generic product considered therapeutically equivalent to four brand versions, including Synthroid®, Levoxyl®, Levothroid® and Unithroid®.
Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey, L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas. For more information about Mylan, please visit www.mylan.com.
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