FDA Corrects Withdrawal of Approval for 10 Abbreviated New Drug Applications

Summary

The FDA is correcting a notice that announced the withdrawal of approval for 10 abbreviated new drug applications, including Ribavirin Capsules and Ribavirin Tablets, after receiving a withdrawal request from Kadmon Pharmaceuticals, LLC. The FDA has reinstated the approval of these applications due to timely requests from Kadmon Pharmaceuticals, LLC.