Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product is available in 45mg and 60mg lyophilized cake or powder single dose vials for subcutaneous injection. The recommended starting dose is 0.3mg/kg and target dose 0.7mg/kg every three weeks. Winrevair was granted Breakthrough Therapy Designation by the FDA
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