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 ...
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 ...
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 ...
On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.’s AMPH Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, ...
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 ...
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, ...
Amphastar Pharmaceuticals, Inc. AMPH, a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, ...
Viatris Chief R&D Officer Philippe Martin said, "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 ...
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