Amphastar Pharmaceuticals Secures FDA Approval for Generic Iron Sucrose Injection for Treating Iron Deficiency Anemia

Reuters

08/11

<a href="https://laohu8.com/S/AMPH">Amphastar Pharmaceuticals</a> Secures FDA Approval for Generic Iron Sucrose Injection for Treating Iron Deficiency Anemia

Amphastar Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for their Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP. This approval applies to single-dose vials in dosages of 50mg/2.5mL, 100mg/5mL, and 200mg/10mL. The iron sucrose injection is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease. Dr. Jack Zhang, Amphastar's President and CEO, expressed enthusiasm for the approval, highlighting the company's commitment to developing complex generics and maintaining high regulatory standards. The product is expected to launch in the third quarter of 2025. This development positions Amphastar to enter a market where existing sales for Venofer®, a comparable product, reached approximately $513 million over the past year.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amphastar Pharmaceuticals Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1058518) on August 11, 2025, and is solely responsible for the information contained therein.

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This approval applies to single-dose vials in dosages of 50mg/2.5mL, 100mg/5mL, and 200mg/10mL. The iron sucrose injection is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease. Dr. Jack Zhang, Amphastar's President and CEO, expressed enthusiasm for the approval, highlighting the company's commitment to developing complex generics and maintaining high regulatory standards. The product is expected to launch in the third quarter of 2025. This development positions Amphastar to enter a market where existing sales for Venofer®, a comparable product, reached approximately $513 million over the past year.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amphastar Pharmaceuticals Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1058518) on August 11, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250811:nNDL6GYZby:1","article_id":"2558065619","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2558065619","pubTimestamp":1754906487,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Amphastar Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration  has granted approval for their Abbreviated New Drug Application  for Iron Sucrose Injection, USP. 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