martes, 28 de febrero de 2017

Patient Network Newsletter- February 15, 2017 | APPROVALS

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Medical Product Approvals
FDA Approved
FDA approves drug to treat Duchenne muscular dystrophy
The FDA approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Emflaza is a corticosteroid that works by decreasing inflammation and reducing the activity of the immune system.
Corticosteroids are commonly used to treat DMD across the world. This is the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use in the United States. More information
Nivolumab for Treatment of Urothelial Carcinoma
The FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. More information
FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders The FDA permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type I (MPS I), PompeGaucher and Fabry. It is the first newborn screening test permitted to be marketed by the FDA for these disorders.
LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly. More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

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