First-time generic approvals are always good for the public and the industry. Through June, there were only 34 first approvals for the calendar year (an average of about 5.6 a month) and it looked like 2018 was going to be a slow year. Then came the July first‑time approval postings (here), where thirteen first-time generic approvals were announced.
While this represents a banner month, it is difficult to tell whether any were actually first‑cycle approvals. There is also a chance that some were previously tentatively approved and moved to full approval. While the FDA provided the number of first‑cycle approvals in its Activities Report of the Generic Drugs Program – Monthly Report, it did not identify which products were first‑cycle approvals.
Browse the list as there are a number of interesting first-time generics among the July approval group.
