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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:  08/29/2019
 
Trade Name:  Riomet ER
 
Generic Name or Proper Name (*):  metformin hydrochloride
 
Indications Studied:  Type 2 diabetes mellitus in pediatric patients 10 years and older
 
Label Changes Summary:  *Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years and older with type 2 diabetes mellitus have been established. *Use of for this indication is supported by evidence from adequate and well-controlled studies of metformin HCl immediate-release tablet in adults with additional data from a controlled clinical study using metformin HCl immediate-release tablets in 73 pediatric patients 10 to 16 years old with type 2 diabetes mellitus. *Safety and effectiveness of have not been established in pediatric patients less than 10 years old. *New dosage form.
 
PREA(P):  P
 
Sponsor:  Sun Pharmaceutical Industries
 
NNPS:  FALSE
 
Therapeutic Category:  Antidiabetic
 
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