Expands access to much-needed iron therapy for millions of US patients Builds Sandoz portfolio of high-quality injectable iron therapies and sets stage for future launches Strengthens US supply of ...

(RTTNews) - Viatris (VTRS) announced the FDA has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia in adult and pediatric patients with ...

Approval Granted with Competitive Generic Therapy Eligibility for 100mg/5mL and 200mg/10mL Strengths; Provides Eligibility for 180 Days of Exclusivity Viatris Chief R&D Officer Philippe Martin said, ...

On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s (NASDAQ:AMPH) Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, ...

Viatris (NASDAQ:VTRS) announced on Monday that the U.S. FDA has approved its Iron Sucrose Injection, USP, as a generic product targeting Venofer marketed by Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) ...

The Food and Drug Administration has given Viatris permission for iron sucrose injection, an intravenous iron replacement product used to treat iron deficiency anemia in adult and pediatric patients ...

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 ...

The US Food and Drug Administration (FDA) released new draft guidance for industry on 27 March entitled Bioequivalence (BE) Recommendations for Iron Sucrose. The guidance instructs industry how to ...

Approval Granted with Competitive Generic Therapy Eligibility for 100mg/5mL and 200mg/10mL Strengths; Provides Eligibility for 180 Days of Exclusivity PITTSBURGH, Aug. 11, 2025 /PRNewswire/ -- Viatris ...