FDA Approves Amneal's Pyridostigmine Bromide Extended-Release Tablets

Amneal Pharmaceuticals, Inc., a global pharmaceutical company based in the United States, has announced that its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg has been approved by the U.S. Food and Drug Administration (FDA). This medication is designed to be taken once daily and is intended for use by the U.S. Armed Services and U.S. allies as a pretreatment against the lethal effects of soman nerve agent poisoning in adults.

The development of PB ER 105 mg tablets is significant as it aims to improve patient compliance by providing a steady 24-hour release of the drug's therapeutic benefits. This new formulation offers a more convenient alternative to the current pyridostigmine bromide product, which needs to be administered every eight hours, requiring service members to self-administer the medication three times a day.

Amneal developed this innovative product using its advanced GRANDE® drug delivery technology, which allows for sustained release of the medication through a sophisticated gastric retention system. The project received partial funding from the U.S. government under Agreement W911QY-21-9-0018 and was developed with the support of the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, expressed their pride in receiving the second NDA approval of the year, following the recent approval of CREXONT for Parkinson's disease. They highlighted the company's expertise in developing innovative product formulations and their ongoing collaboration with the U.S. government to create new solutions. The approval of pyridostigmine bromide extended-release tablets underscores Amneal's commitment to supporting the U.S. military.

The most serious adverse reactions reported in connection with PB ER include breathing difficulties, dizziness, and loss of consciousness. Other adverse reactions observed were dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity.

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, New Jersey, is dedicated to the development, manufacturing, and distribution of a wide range of pharmaceutical products, with a portfolio that includes over 280 generic and specialty pharmaceuticals primarily available in the United States. In addition to its Generics segment, which covers a broad spectrum of complex product categories and therapeutic areas such as injectables and biosimilars, Amneal also has a growing Specialty segment focused on central nervous system and endocrine disorders. Moreover, through its AvKARE segment, the company serves as a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.