Bristol pravastatin/aspirin co-package
Executive Summary
Bristol-Myers Squibb's NDA (21-387) for a pravastatin/aspirin co-package (tentatively named Pravaguard) will return to FDA's Cardiovascular & Renal Drugs Advisory Committee for consideration on the afternoon of July 18. The NDA was resubmitted following a Jan. 18 meeting at which the committee voted against approval for long-term management to reduce the risk of cardiovascular events in patients with clinically evident coronary heart disease (1"The Pink Sheet" Jan. 21, p. 7)...
You may also be interested in...
Pravachol/Aspirin Fixed-Dose Inflexibility May Lead To Undertreatment
Bristol-Myers Squibb's Pravachol/Bufferin titration inflexibility was cited as a main issue by FDA's Cardiovascular & Renal Drugs Advisory Committee in voting against approval of the fixed-dose combination of the cholesterol-lowering and aspirin products
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.