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 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 ...
Amphastar Pharmaceuticals, Inc. AMPH, a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, ...
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 ...
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, ...
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 ...
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 ...
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