Novartis Lescol XL
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Extended-release 80 mg tablet formulation of fluvastatin produced up to a 38% median decrease in low-density lipoprotein cholesterol in patients with dyslipidemia compared to Lescol 40 mg in Phase III clinical trials, the company said, announcing the Oct. 6 approval of the new tablet. "A 25% median decrease in triglycerides and a 13% mean increase in high-density lipoprotein cholesterol in patients with primary mixed dyslipidemia (Fredrickson Type IIb)" compared to Lescol 40 mg was also seen in the trials, the company reported. The NDA for the extended-release formulation was submitted Dec. 8, 199