![]() The FDA also concurrently approved a companion diagnostic device, the therascreen EGFR RGQ PCR Kit (Qiagen), to help determine whether a patient’s lung cancer cells express the EGFR mutations.Īfatinib, a tyrosine kinase inhibitor, is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif and a Diagnostic Test For Lung CancerĪfatinib (Gilotrif, formerly Tomtovok, Boehringer Ingelheim) is now approved for patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors express specific epidermal growth factor receptor (EGFR) gene mutations. For more information, please see the Pharmaceutical Approval Update column, page 445. A patient medication guide will be dispensed at each refill. All paroxetine drugs approved for treating depression have a boxed warning about a risk of suicide in children and young adults. Paxil (GlaxoSmithKline) and Pexeva (Noven) contain higher doses of paroxetine and approved for major depressive disorder, obsessive–compulsive disorder, panic disorder, and generalized anxiety disorder. ![]() Other approved therapies for menopausal vasomotor symptoms contain either estrogen alone or estrogen plus a progestin.īrisdelle capsules contain 7.5 mg of paroxetine and are taken once daily at bedtime. This product is the only nonhormonal therapy for hot flashes approved by the FDA. The FDA has approved paroxetine mesylate (Brisdelle, Noven), a selective serotonin reuptake inhibitor, to treat moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. ![]()
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