Specialty Pharma Journal Specialty, Precision & Technology
26 April 2016 AstraZeneca today announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment …
Tag Archives: lesinurad
April, 2016
December, 2015
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28 December
AstraZeneca’s Zurampic Receives FDA Approval for Patients with Gout
22 December 2015 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved ZURAMPIC® (lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an …
November, 2015
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9 November
AstraZeneca Announces Positive Late-Stage Results for the Treatment of Hyperuricemia Associated with Gout
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive subanalysis data of the Phase III lesinurad studies (CLEAR1, CLEAR2 and CRYSTAL) for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).The results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well …
January, 2015
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22 January
European Health Regulators to Review AstraZeneca’s Investigational Gout Drug
The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorization application for its investigational gout drug, which the company acquired through its acquisition of Ardea Biosciences. AstraZeneca said that the EMA accepted its application for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in gout patients. Lesinurad is a …