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

UsernamePublicRestriction
UsernamePublicRestriction

Novartis files Lescol/Lescol XL sNDAs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis submits sNDAs for Lescol and Lescol XL (fluvastatin) for secondary prevention of cardiovascular events in patients who have undergone percutaneous coronary intervention (PCI) August 1, based on the four-year Lescol Intervention Prevention Study (LIPS). The study, published June 26 in the Journal of the American Medical Association, found that fluvastatin treatment in patients "with average cholesterol levels undergoing their first PCI significantly reduces the risk of major adverse cardiac events." Novartis is touting fluvastatin as the first statin to seek such an indicatio

You may also be interested in...



QUOTED. 19 April 2021. Jeff Shuren & William Maisel

Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.

Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021

With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.

Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.

Topics

UsernamePublicRestriction

Register

PS001990

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

Cancel