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Aczone Gel
儿科标签批准日期
2019/9/10 0:00:00
标签更改摘要
- Expanded the patient population to down to 9 years of age and older; previously approved down t12 years.
- Use in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years and older and with additional pharmacokinetic and safety data in pediatric patients 9 to 11 years from an open label study of 100 patients with acne.
- The adverse reactions in clinical trials was similar to the vehicle control group.
- Safety and effectiveness have not been established in pediatric patients belo 9 years of age.
- Postmarketing study.