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Novartis Prexige Is “Not Approvable;” COX-2 Launch At Least Two Years Away

Executive Summary

The liver safety profile of Novartis' Prexige appears to be one factor behind FDA's request for additional studies on the COX-2 inhibitor prior to approval in osteoarthritis and acute pain

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Novartis’ Prexige withdrawn in Australia

The Australian government is withdrawing Novartis' Prexige (lumiracoxib) after two patients died of liver injury following treatment with the COX-2 inhibitor. The Australian Therapeutic Goods Administration says Aug. 10 that since March it had received eight reports of serious hepatic adverse reactions associated with the drug. Novartis said approximately 60,000 people have been treated with Prexige in Australia and that the majority received the 200 mg formula. The company has an NDA for a 100 mg dose pending with the FDA. In 2003, FDA issued a "not approvable" letter for Prexige citing concerns about the drug's potential for liver toxicity (1"The Pink Sheet" Sept. 29, 2003, p. 20)...

Novartis’ Prexige withdrawn in Australia

The Australian government is withdrawing Novartis' Prexige (lumiracoxib) after two patients died of liver injury following treatment with the COX-2 inhibitor. The Australian Therapeutic Goods Administration says Aug. 10 that since March it had received eight reports of serious hepatic adverse reactions associated with the drug. Novartis said approximately 60,000 people have been treated with Prexige in Australia and that the majority received the 200 mg formula. The company has an NDA for a 100 mg dose pending with the FDA. In 2003, FDA issued a "not approvable" letter for Prexige citing concerns about the drug's potential for liver toxicity (1"The Pink Sheet" Sept. 29, 2003, p. 20)...

Novartis Is Confident In Prexige’s Prospects Despite Arcoxia AC Debacle

Novartis is confident its COX-2 inhibitor Prexige does not raise the same safety concerns cited by an FDA advisory committee in recommending against approval of Merck's COX-2 agent Arcoxia

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