Latest approvals by the US FDA
• The proton pump inhibitor (PPI) Nexium (esomeprazole magnesium) is indicated for short-term treatment of gastroesophageal reflux disease (GERD) in children ages 1 to 11 years old. Nexium is manufactured by AstraZeneca [1].
• Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free is a new treatment for hemophilia A. Hemophilia A is a hereditary blood-clotting disorder that affects mainly males. It is caused by a mutation of the factor VIII, resulting in clotting factor VIII deficiency. Xanthia is a genetically engineered version of factor VIII. It is manufactured by Wyeth Pharmaceuticals Inc. [2].
• The Interleukin-1 blocker Arcalyst (rilonacept) is an orphan drug indicated for the treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders. CAPS are very rare conditions of inflammation. Orphan drugs are drugs intended for the treatment of rare diseases. To make it worthwhile for drug companies to develop such drugs in the US, manufacturers of orphan drugs enjoy tax incentives and longer period of exclusivity as provided for by the US Orphan Drug Act. Arcalyst is manufactured by Regeneron Pharmaceuticals Inc. [3].
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