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Amphastar Announces FDA Approval for Iron Sucrose Injection, USP

1. FDA approves Amphastar's iron sucrose injection for iron deficiency anemia. 2. Product shows bioequivalence to Venofer® targeting chronic kidney disease.

FDA Approval
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Why Bullish?

FDA approval typically boosts stock prices in biopharma. Historical approval in similar sectors shows significant value increases.

How important is it?

FDA approval opens new revenue streams; market validation enhances investor confidence.

Why Short Term?

Immediate market reaction expected post-approval. Past examples show quick stock price surges following FDA announcements.

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According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer ® for the treatment of iron deficiency anemia in patients with chronic kidney disease RANCHO CUCAMONGA, CA / ACCESS Newswire / August 11, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002. Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

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