Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal's GRANDE drug delivery technology

Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company"), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg.

PB ER 105 mg tablets are a once-daily, orally administered product indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults developed for the U.S. Armed Services and U.S. allies. This product offers potential for improved compliance and steady 24-hour release of the drug's therapeutic benefit, which is intended to provide an alternative to the current PB product that is administered every eight hours and avoiding the need for service members to self-administer three times a day.

This product was not previously disclosed and was developed with Amneal's GRANDE drug delivery technology, which is an advanced gastric retention system that allows for sustained delivery drug release. This project was funded in part by the U.S. government under Agreement W911QY-21-9-0018.