According to a posting yesterday (here), the Office of Generic Drugs (OGD) approved 61 first-time generic products so far in 2016, with another quarter to go. When we look at the first approvals, there were multiple approvals for 10 products (so it appears that 51 different entities were approved (some of which may have been new dosage forms or strengths of previously approved products).
This is great work by OGD, as these products can now compete in markets for which there were no previous generic competitors. We cannot tell if any of these first-time approvals were first-cycle approval, although many appear to be older products given the ANDA numbers assigned. It is also possible that some approvals were delayed for patent or exclusivity issues and, thus, drawing any conclusions about the rate or speed of approval is not possible because the entire administrative record is not available.
