Viatris stock rises after FDA approval of first generic iron sucrose Investing.com -- Viatris Inc (NASDAQ:VTRS) stock rose 2.6% following the U.S. Food and Drug Administration’s approval of the company’s Iron Sucrose Injection, USP, the first generic version of Venofer® Injection. The intravenous iron replacement product is used to treat iron deficiency anemia in adult and pediatric patients with chronic kidney disease. The medication will be available in single dose vials in three strengths: 50 mg/2.5mL, 100mg/5mL, and 200mg/10mL. The FDA granted Viatris a competitive generic therapy designation for the 100 mg/5 mL and 200 mg/10 mL strengths, which provides expedited review and eligibility for 180 days of market exclusivity upon commercial launch. "The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia and a testament to Viatris’ advanced technical and manufacturing capabilities," said Philippe Martin, Viatris Chief R&D Officer. The company developed the complex injectable product in-house after working closely with the FDA for several years. Viatris noted that its pipeline includes additional complex injectables across multiple therapeutic areas, including ferric carboxymaltose injection, another iron replacement product. According to IQVIA data cited by Viatris, Venofer® had annual sales of approximately $515 million in the U.S. as of June 30, 2025. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Amphastar stock rises after FDA approves generic iron sucrose injection Investing.com -- Amphastar Pharmaceuticals (NASDAQ:AMPH) stock gained 4% after the company announced FDA approval for its generic version of iron sucrose injection, a treatment for iron deficiency anemia in patients with chronic kidney disease. The newly approved product, previously referred to as AMP-002, will be available in three dosage forms: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials. Amphastar plans to launch the product in the third quarter of 2025. "We are delighted to announce the FDA approval of our generic iron sucrose injection," said Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer. "This approval, once again, demonstrates our dedication to developing complex generics and leveraging cutting-edge, in-house manufacturing expertise to produce both active pharmaceutical ingredients and finished drug products under the highest regulatory standards in the U.S." The approval represents a significant opportunity for Amphastar, as the reference product Venofer® generated approximately $513 million in U.S. sales for the 12 months ended June 30, 2025, according to IQVIA data. Amphastar’s pipeline includes three ANDAs and one biosimilar insulin candidate currently under FDA review, targeting products with a combined market size exceeding $2.5 billion. The company is also developing three biosimilar products targeting a market exceeding $6 billion and two generic products aimed at a market of over $1 billion. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C. Don't miss out on the next big opportunity! Stay ahead of the curve with ProPicks AI – 6 model portfolios fueled by AI stock picks with a stellar performance this year... In 2024 alone, ProPicks AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. That's an impressive track record. With portfolios tailored for Dow stocks, S&P stocks, Tech Stocks, and Mid Cap stocks, you can explore various wealth-building strategies. So if AMPH is on your watchlist, it could be very wise to know whether or not it made the ProPicks AI lists.

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