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Amphastar Pharmaceuticals Receives FDA Approval for Naloxone Hydrochloride Nasal Spray 4mg
RANCHO CUCAMONGA, CA / ACCESSWIRE / March 8, 2023 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") announced that the U.S. Food
About this update from Amphastar Pharmaceuticals, Inc.
[{"type":"text","content":"RANCHO CUCAMONGA, CA / ACCESSWIRE / March 8, 2023 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) (\"Amphastar\" or the \"Company\") announced that the U.S. Food and Drug Administration (\"FDA\") has granted approval of its New Drug Application (\"NDA\") for naloxone hydrochloride nasal spray 4mg, which is delivered utilizing the Company's proprietary nasal delivery device. Naloxone hydrochloride nasal spray 4mg is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression for adult and pediatric patients.Dr. Jack Zhang, Amphastar's President and Chief Executive Officer commented: \"The approval of our naloxone hydrochloride nasal spray marks an important step in helping alleviate the opioids crisis as patients can further broaden their access to a critical product. Utilizing our innovative device platform, the approval of naloxone hydrochloride nasal spray validates our technical capabilities as we can leverage this towards our intranasal pipeline.\"According to IQVIA, the U.S. sales of naloxone hydrochloride nasal spray 4mg in 2022 was approximately $250 million for the 12 months ended December 31, 2022.Pipeline InformationThe Company currently has three ANDAs on file with the FDA targeting products with a market size of over $3 billion, three biosimilar products in development targeting products with a market size of over $11 billion, and six generic products in development targeting products with a market size of over $9 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2022. The Company is developing multiple proprietary products with injectable and intranasal dosage forms.Amphastar's Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.Company InformationAmphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. M...