FDA announced (here) that, so far this CALENDAR year through March 24th, the Office of Generic Drugs has approved 11 first-time generics. That appears to be a good start for the first three months of the year. All the first-time approvals can be viewed at the link above.
Remember that not all first approvals will immediately be available in the marketplace. Approvals could be based on expiration of a 30-month stay period, or some other reason if the application is otherwise approved they may decide not to market at risk if the patent issues have not been settled. Sometimes firms don’t expect the approval and then it is a matter of completing validation studies and getting the product into the market channels. Nevertheless, it is always good to see a vibrant first generic approvals list.
Some of the brand name products that were subject to first generics include Xyrem, Zyflo – CR, Alkeran, and Namzaric.
We will keep you informed of other first generics as the FDA updates the listing.
