U.S. Food and Drug Administration Approves New Drug Application of Amneals Pyridostigmine Bromide Extended-Release Tablets

Amneal's New Drug Application of Pyridostigmine Bromide Extended-Release Tablets Received US FDA Approval

Amneal Pharmaceuticals, Inc, US based international pharmaceutical firm, issued a statement that FDA has approved its New Drug Application for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg.

The PB ER 105 mg tablets, an orally administered once-daily product developed to pretreat adults against the lethal effects of soman nerve agent poisoning developed for the U.S. Armed Services and U.S. allies. This product may be able to achieve better compliance and a constant 24-hour release of the therapeutic benefit of the drug, designed to serve as an alternative to the current PB product that is administered eight times daily and not require service members to self-administer three times daily.

This drug was not marketed previously and has been developed using Amneal's GRANDE drug delivery technology, which is an advanced gastric retention system that has enabled sustained delivery drug release. This work was partially funded by the United States Government under Agreement W911QY-21-9-0018.

NDA Approval for Amneal, it marks our second within a year, after recent approval of CREXONT for Parkinson's disease treatment. This new therapy of pyridostigmine marks Amneal's capabilities for the development of new and innovative formulations for products and a continued partnership with the U.S. government on new solutions.

The most frequent serious adverse effects included dyspnea, dizziness, and unconsciousness. Other side effects reported and also documented were dysmenorrhea, epistaxis, blindness in one eye, and diminished light sensitivity.

About the Company

Amneal Pharmaceuticals is one of the industry leaders in providing world-class generic and specialty pharmaceuticals and related value-added products. The headquarters of the company is in the United States, but it specializes in developing and manufacturing distributing high-quality generic pharmaceuticals but has an interest in specialty pharmaceuticals. It became one of the largest suppliers of affordable medicines in the U.S., offering a great variety of tablets, capsules, injectables, and topical treatments. Amneal focuses on specialty products, including niche therapeutic areas that the company considers of importance, such as central nervous system disorders, oncology, and endocrine diseases. Furthermore, the company has entered the biosimilars space to make expensive biologic drugs more affordable.

Amneal maintains its high standards of production while scrupulously adhering to rules and regulations due to grounds of its global manufacturing and distribution base. Its focus on research and development, especially on complex generics, has given it an edge in the market. Amneal continues its expansion through strategic acquisition and organic growth as well as partnerships-all hallmarks of this company's faithful mission: namely improving the outcomes of patients by means of high-quality, affordable healthcare solutions.