Bullish indicating open at $55-$60, IPO prices at $37
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.