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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:  05/23/2019
 
Trade Name:  Slynd
 
Generic Name or Proper Name (*):  drospirenone
 
Indications Studied:  Prevention of pregnancy
 
Label Changes Summary:  *Safety and efficacy have been established in females of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and users 16 years and older. *Study CF111/304 evaluated the bleeding associated with Slynd in females =12 years of age. Bleeding data were generally consistent with those from Study CF111/303 in adult females. *Use of this product before menarche is not indicated. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Exeltis USA, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Contraceptive
 
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