Elevidys Pregnancy Warnings
There are no controlled data in animal studies or human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.
This drug is not intended for use in pregnant women.
US FDA pregnancy category: Not assigned
Risk summary: This drug is not intended for use in pregnant women.
See references