![]() ![]() and its partner Endo Pharmaceuticals Inc. OctoBioDelivery Sciences International, Inc. Read more.īelbuca™ (buprenorphine hydrochloride) Buccal Film The FDA approved Pradaxa ® in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Food and Drug Administration granted accelerated approval to Praxbind ® (idarucizumab), for use in patients who take the anticoagulant Pradaxa ® (dabigatran) during emergency situations, when there is a need to reverse Pradaxa’s ® blood-thinning effects. Factor X deficiency is an inherited disorder, affecting men and women equally, where the blood does not clot as it should. In healthy individuals, the Factor X protein activates enzymes to help with normal blood clotting in the body. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency. ![]() ![]() Food and Drug Administration approved Coagadex ®, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Read more.Ĭoagadex ® (coagulation factor X (human)) But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. Food and Drug Administration approved Veltassa™ (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Veltassa™ (patiromer) for Oral Suspension RxS Clinical Insight: Note Strensiq™ has orphan drug status. It is characterized by defective bone mineralization that can lead to rickets and softening of the bones that result in skeletal abnormalities. HPP is a rare, genetic, progressive, metabolic disease, in which patients experience devastating effects on multiple systems of the body, leading to severe disability and life-threatening complications. Food and Drug Administration approved Strensiq™ (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. Food and Drug Administration approved Yondelis ® (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS)-liposarcoma and leiomyosarcoma-that cannot be removed by surgery (unresectable) or is advanced (metastatic). Imlygic™ is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die. Imlygic™, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Food and Drug Administration approved Imlygic™ (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. ![]() Welcome to the first November edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place. ![]()
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