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n Obstetrics and Gynaecology Forum - New labeling for all estrogen and estrogen / progestogen therapies - FDA : product news

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Abstract

Extracted from text ... New labeling for all estrogen and estrogen / progestogen therapies - FDA As a consequence of data from the Women's Health Initiative study (WHI), the FDA has advised that revisions be made to all manufacturers labeling of estrogen (ET) and estrogen/progestogen (EPT) therapies. This reflects the FDA's perspective that, in the absence of new safety information, the effects of EPT therapy seen in the WHI study apply to the entire class of ET and EPT, pending further clinical studies. Some labeling revisions include:- Indications for vulvar and vaginal atrophy are restated for moderate to severe symptoms of vulvar and ..

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/content/medog/13/2/EJC73167
2003-04-01
2016-12-05
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