Got my NDAs and ANDAs a bit mixed up in this morning’s post (here) regarding potential first cycle approvals for ANDAs. The 8-month tentative approval for NDA 210064 was for a 505(b)(2) application and not an ANDA. Let’s give credit where credit is due to the New Drugs Review Division for that one. But the fact that we are seeing some faster and potential first cycle approvals for ANDAs is also a credit to the Office of Generic Drugs, the Office of Pharmaceutical Quality, as well as the Office of Compliance and all the other team members that contribute to the approval effort.
I guess I just wanted to see what we all want to see –more first cycle approvals. Sorry about that folks!