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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  10/21/2010
Trade Name:  Lo Loestrin Fe
Generic Name or Proper Name (*):  norethindrone acetate/ ethinyl estradiol
Indications Studied:  Prevention of pregnancy
Label Changes Summary:  * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years * Use before menarche is not indicated* New dose and dosing regimen
Product Labeling:  Labeling  Opens a new window
Sponsor:  Warner Chilcott
Therapeutic Category:  Contraceptive