FDA news roundup: Cancidas approved, BPA meeting scheduled
The US Food and Drug Administration (FDA) has approved the inclusion of efficacy, safety, and dosing data for patients ages 3 months to 17 years in the label for Merck's Cancidas (caspofungin acetate).
Drug approval
The US Food and Drug Administration (FDA) has approved the inclusion of efficacy, safety, and dosing data for patients ages 3 months to 17 years in the label for Merck's Cancidas (caspofungin acetate).
The expanded labeling makes Cancidas the first echinocandin therapy approved in the US for pediatric patients with indicated fungal infections, according to Merck.
Public meeting scheduled
The FDA announced that it would hold a public meeting regarding the safety of bisphenol A (BPA) on September 16, according to Reuters.
This April, Health Canada issued a report that found the amount of BPA exposure in plastic products such as baby bottles is unsafe for newborns and infants, and moved to ban the chemical. However, the FDA stated in May that according to its assessment, the exposure to BPA in these products is well below the levels that would cause adverse health effects.
