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Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
Posted 29 Dec 2016 by Drugs.com
Lexington, Mass. – December 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved Adynovate for use in sur ...
Posted 16 Nov 2015 by Drugs.com
November 13, 2015 – The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. ...