FDA Approves Amphastar's Teriparatide Prefilled Pen for Osteoporosis

Reuters12-15

FDA Approves Amphastar's Teriparatide Prefilled Pen for Osteoporosis

Amphastar Pharmaceuticals Inc. has received FDA approval for its Abbreviated New Drug Application (ANDA) for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO®, providing a new, affordable option for daily osteoporosis therapy. Amphastar plans to launch the product by the end of the 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: 1117324) on December 15, 2025, and is solely responsible for the information contained therein.

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The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO®, providing a new, affordable option for daily osteoporosis therapy. Amphastar plans to launch the product by the end of the 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: 1117324) on December 15, 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":"BK4585","symbol_name":"ETF&股票定投概念","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251215:nNDL7kD9x0:1","article_id":"2591648619","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2591648619","pubTimestamp":1765796453,"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 received FDA approval for its Abbreviated New Drug Application  for teriparatide injection, USP 560 mcg/2.24mL  single-patient-use prefilled pen. 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The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO®, providing a new, affordable option for daily osteoporosis therapy. Amphastar plans to launch the product by the end of the year.\n      \n\nDisclaimer: 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. 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