T
he British agency regulating medicines and health products said that the license of this anti-arthritis had been suspended because of "concerns about possible liver damage"The British authorities have suspended the drug from Novartis against arthritis, Prexige, because of concerns about possible liver damage, according to a release of the British agency regulating medicines and health products (MHRA) published Monday.
The MHRA suspend the license of Prexige because of concerns about possible liver damage patients' treatment of Prexige, according to the release.
"The latest figures indicate an increase in the number of cases of serious liver reaction with the seizure of the permitted dose of 100 mg," the MHRA said, adding that "in some cases these reactions have been associated with a short-term "Less than a month.
Novartis, contacted by AFP, said "working on a response", without giving further details.
The U.S. Agency for Drugs (FDA) had issued in late September a "not approvable letter" for Prexige, retired in August of the Australian market after the deaths of two patients.
It was the second attempt to allow the drug to the USA for which Novartis expects a "blockbuster" (1 billion dollars in sales).
Novartis withdrew its first application in 2006, after the withdrawal of Vioxx, a drug of U.S. pharmaceutical group Merck belonging to the same class (coxibe) that Prexige.
The Australian authorities have banned in August the marketing of Prexige, after the death of two people in the country.
The Prexige is prescribed to relieve pain associated with osteoarthritis, pain post-surgery, dental and related to menstrual pain. He generated the first half of 2007 a turnover of 52 million dollars (38 million euros). (source AFP)
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