Amneal's New Drug Application For Pyridostigmine Bromide Extended-Release Tablets Approved by FDA for Military Use

Amneal Pharmaceuticals, Inc., a U.S.-based global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. These PB ER 105 mg tablets were once a daily oral medication designed for use in adults as a pre-treatment against the deadly effects of soman nerve agent poisoning, specifically for the U.S. Armed Forces and allied military. The medication can deliver uniformly sustained, 24-hour therapeutic effects through enhanced compliance and the minimized use of the presently recommended eight-hourly dosing schedule.

The drug is produced using Amneal's patented GRANDE drug delivery technology that induces gastric retentivity, wherein the drug is released over a prolonged period. The drug development has been partially funded by the US government under Agreement W911QY-21-9-0018. The most commonly reported severe side effects included difficulty breathing, dizziness, and fainting. Additional side effects noted were menstrual pain, nosebleeds, partial vision loss in one eye, and reduced sensitivity to touch.

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, said in a statement, “Amneal is proud to receive our second NDA approval this year after the recent approval of CREXONT for Parkinson’s disease. This new pyridostigmine therapy speaks to Amneal’s expertise in developing innovative product formulations and our ongoing work with the U.S. government on new solutions. With the approval of pyridostigmine bromide extended-release tablets, we proudly support the U.S. military.”