Novartis’ Prexige withdrawn in Australia
Executive Summary
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)...
You may also be interested in...
Novartis Prexige Is “Not Approvable;” COX-2 Launch At Least Two Years Away
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
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.