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Drug Approvals

Pharmaceutical company receives FDA approval for levothyroxine sodium tablets

Published in Medical Letter on the CDC and FDA, August 15th, 2004

Mylan Laboratories Inc. (MYL) announced that the U.S. Food and Drug Administration has granted approval for the company to market its currently approved Levothyroxine Sodium Tablets as a bioequivalent and therapeutically equivalent (i.e., AB-rated) product to Jones Pharma Inc.'s Levoxyl Tablets.

The Mylan product is currently available to the trade in 0.025 mg, 0.050 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg strengths.

Mylan is the first company to offer Levothyroxine Sodium Tablets as AB-rated to Levoxyl, Unithroid and Synthroid.

Mylan Laboratories Inc. is a pharmaceutical company...

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