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Amphastar报告FDA批准特立帕肽注射剂
2025-12-15 19:33
- Amphastar製藥(AMPH) 0
- 禮來(LLY) 0
- 艾昆緯(IQV) 0
- Amphastar Pharmaceuticals (AMPH) said that the U.S. Food and Drug Administration has approved the company's abbreviated new drug application 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 (LLY) FORTEO.
- According to IQVIA, the overall U.S. sales for teriparatide injection were approximately $585 million for the 12 months ended September 30, 2025.
- Amphastar (AMPH) plans to launch its teriparatide injection by the end of the year.
- Amphastar Pharmaceuticals (AMPH) +4.8% premarket.
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