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, ...
Amphastar Pharmaceuticals Inc (AMPH) reports robust sales growth in key products and strategic pipeline expansions, despite facing increased competition and profitability pressures.
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 ...
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, ...
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 ...
Sandoz, the global leader in affordable medicines, announced the US launch of its generic iron sucrose injection following recent approval by the US Food and Drug Administration (FDA). The product is ...
The comparative study aimed to analyze AEs as well as estimate the associated medical costs for 4 IV iron preparations. Hypersensitivity and anaphylactic reaction rates reported to the US Food and ...
While the risk of anaphylaxis after administration of IV iron product was low among older adults, it was more common after certain iron products, researchers found. The highest adjusted incidence ...
PRINCETON, N.J., September 24, 2025--(BUSINESS WIRE)--Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today announced the US launch of its generic iron sucrose injection ...