Liqmeds Worldwide Limited: mycophenolate mofetil

Please refer to your new drug application (NDA) dated and received March 8, 2022, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for © (mycophenolate mofetil oral suspension).

As described in our correspondences dated June 22 and October 17, 2022, in accordance with section 505-1 of the FDCA, we have determined that a risk evaluation and mitigation strategy (REMS) is necessary for mycophenolate mofetil to ensure that the benefits of the drug outweigh the risks of first trimester pregnancy loss and congenital malformations.

We reserve any additional comments on the proposed labeling until the application is otherwise adequate.