Amneal obtains FDA OK for pyridostigmine bromide ER tablets
Amneal has received the Food and Drug Administration’s approval for pyridostigmine bromide ER tablets, 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 the 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 avoids the need for service members to self-administer three times a day.
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The product was developed with Amneal’s Grande drug delivery technology, an advanced gastric retention system that allows for sustained delivery of drug release. The development was funded in part by the U.S. government under Agreement W911QY-21-9-0018.
“Amneal is proud to receive our second NDA approval this year, after the recent approval of CREXONT for Parkinson’s disease," said Chirag and Chintu Patel, co-CEOs of Amneal. "This new pyridostigmine therapy speaks to Amneal’s expertise in developing new 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 are proudly supporting the U.S. military.”
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