Contemporary Pediatrician, Digital Edition, September 2012

Somapacitan was non-inferior and had a similar safety profile and clinical outcomes compared to once-daily somatropin in improving yearly growth rates.

Safety, phosphate level gains, and immunogenicity data offer encouraging signals in the pivotal trial.

The administration has set a goal date of October 31 to complete a safety review, public comment period, and to take "appropriate action" in efforts to remove products from the market.

According to the agency, it is seeking public input to "determine whether existing nutrient requirements should be revised based on latest scientific data."