Amneal Pharma: FDA Approves NDA For Pyridostigmine Bromide Extended-Release Tablets

(RTTNews) - Amneal Pharmaceuticals (AMRX) announced it has received FDA approval of its New Drug Application for Pyridostigmine Bromide Extended-Release Tablets USP 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.

The company noted that this product was not previously disclosed and was developed with Amneal's GRANDE drug delivery technology, which is an advanced gastric retention system. This project was funded in part by the U.S. government.

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