Amneal Pharmaceuticals (AMRX) has announced that the FDA has approved its New Drug Application for Pyridostigmine Bromide Extended-Release 105 mg Tablets. These tablets are designed for once-daily oral administration, serving as a pretreatment for adults against the deadly effects of soman nerve agent exposure. This medication is intended for use by the U.S. Armed Services and allied forces.
Importantly, Amneal highlighted that this product had not been previously disclosed and was developed utilizing Amneal's proprietary GRANDE drug delivery system, which features an advanced gastric retention mechanism. The project received partial funding from the U.S. government.
