Biopharma · FDA Approvals · Stock
AMPH Amphastar
Amphastar Pharmaceuticals Inc is a bio-pharmaceutical company focusing on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin active pharmaceutical ingredient (or insulin API products. The company's finishe…
Assets on file: naloxone
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AMPHAmphastarAmphastar wins FDA approval for OTC naloxone nasal spray Rextovy
FDA approved Amphastar’s Rextovy (4 mg naloxone HCl nasal spray) for nonprescription sale, allowing direct consumer purchase without a prescription. The approval expands the number of OTC naloxone products available, increasing consumer access and potential price competition. The product is indicated for the emergency treatment of opioid overdose and can be sold in pharmacies, convenience stores, and online.
AMPHAmphastarAmphastar Pharmaceuticals, Inc. · complete response letter (BLA 761403)
FDA issued a complete response letter for BLA 761403 dated 2026-02-26.
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