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, ...
Results of the review also found that 18 adverse events occurred in a total of 13 patients (18.1% of patients; 6.6% of infusions). For pediatric patients with inflammatory bowel disease (IBD), ...
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 ...
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 ...
Iron repletion is a very common and necessary therapy for patients with NDDCKD. Oral iron supplementation is frequently not tolerated and sometimes inadequate to replete the body's iron stores. The ...
American Regent announced that it has resumed shipment of all vial sizes of Venofer (iron sucrose injection). On April 21, 2011, American Regent announced the temporary suspension of the distribution ...
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, ...
A total of 100 patients were identified as receiving at least one 300-mg dose of elemental iron i.v. as iron sucrose. Of these patients, 73 had NDDCKD; the remaining 27 patients had a CL cr of ≥60 ...
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