FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and are therefore, no longer FDA-approved.

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

The Food and Drug Administration is advising consumers not to purchase or use ZapMax, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.

The Food and Drug Administration is advising consumers not to purchase or use Kuka Flex Forte, a product promoted and sold for joint pain and arthritis on various websites, including https://botanical-be.com, and possibly in some retail stores.

Unapproved New Drugs/Adulterated/Misbranded