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Home » Brazilian Regulator Reverses Cox-2 Decision
Brazilian Regulator Reverses Cox-2 Decision
Brazil's drug regulator, Anvisa, has issued new guidance on the safety of Cox-2 inhibitors, effectively reversing its decision to withdraw the drugs last year. Anvisa originally withdrew the drugs from circulation in the wake of controversy over US drug major Merck & Co's Vioxx.
The drug safety unit of the regulatory authority, Cateme, has now cleared Pfizer's Celebrex (celecoxib), marketed in Brazil as Celebra for its analgesic and anti-inflammatory indications. The decision, which also includes a number of other products including Arcoxia, Prexige, and Bextra, comes at a time when health authorities worldwide are reassessing risk factors associated with Cox-2 inhibitors.
KEYWORDS Daily International Pharma Alert
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