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Endo's Fortesta receives FDA approval
CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.
The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.
Endo said it planned to introduce Fortesta in the United States early this year.
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Drug approvals low in 2010
NEW YORK — This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.
The Wall Street Journal reported that 21 new drugs were approved through the year, compared with 25 in 2009 and 24 in 2008. The lag came in part due to stricter safety regulations, the newspaper reported.