Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Novartis’ Prexige withdrawn in Australia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

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts