Using Type 9 NDA Designation to Accelerate Multiple Approvals for Your Drug Product

Apr 15, 2021

Often companies submit their original New Drug Application (NDA) and wait for approval of that original NDA before submitting a supplemental NDA with data to support a new indication or claim. This sequential process results in a delay of at least six months (if expedited review) or longer depending on the time for review of the original NDA. The United States Food and Drug Administration (FDA) has a process whereby you can submit more than one original NDA for the same drug product, alleviating the need to wait for approval of the original NDA. One type of NDA that allows for submission prior to approval to the original NDA is the Type 9 NDA. Figure 1 depicts an actual timeline for approval of two NDAs using the Type 9 NDA process and a theoretical timeline to show potential delay if second NDA had been submitted after approval of first NDA.

At Certara, we accelerate medicines
to patients, partnering with life science innovators.  Together with our
partners, we use biosimulation and technology-enabled services to transform
drug discovery and development. For more information visit or

Download Attachment

See all Member News