Without much fanfare, on November 11, 2019, OGD approved the first generic vaginal contraceptive ring. Amneal’s approval showed up today on the Drug@FDA, FDA approved drugs list. It is a therapeutic equivalent to Nuvaring by Organon/Merck. Given the ANDA number, it appears that the application was submitted about early to mid-2018, which by all standards for a complex generic product is somewhat amazing to say the least.
When I was at the Agency, we spoke about the issues associated with vaginal rings and IUDs, and figured that they would undergo very long approval times. Can’t wait to see the summary of approval for this product! Good work Amneal and good work OGD.