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 ...
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) ...
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 Inc (NASDAQ:VTRS) saw its stock increase by 2.6% after the U.S. Food and Drug Administration approved its Iron Sucrose Injection, USP, marking the first generic alternative to Venofer® ...
Viatris and Amphastar Pharmaceuticals both received Food and Drug Administration approval of generic iron sucrose injection products for the treatment of iron deficiency anemia in patients with ...
Amphastar has received permission from the Food and Drug Administration for iron sucrose injection, 50mg/2.5ml, 100mg/5ml and 200mg/10ml in single-dose vials, previously referred to as AMP-002. Iron ...
All 3 strengths of iron sucrose injection are expected to be available “imminently”. The Food and Drug Administration (FDA) has approved the first generic version of Venofer ® (iron sucrose) Injection ...
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 ...
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, ...