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FDA panel recommends approval of Shire's Firazyr
DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.
Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.
HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.
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Pfizer, Acura get FDA OK for Oxecta
NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.
Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.