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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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