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FDA Approval Activities for this Drug…
Lescol Capsules & Lescol XL (fluvastatin sodium) Extended release Tablets, Novartis Pharmaceutical NDA 20-261/S32 & 21-192/S4 9/6/02 9/11/02 9/6/02 Lescol XL (fluvastatin sodium) Extended release Tablets, Novartis Pharmaceutical NDA 21-192 10/6/00 10/20/00 Lescol XL (fluvastatin sodium) Extended release Tablets, Novartis Pharmaceutical NDA 21-192/S2 9/25/01 5/1/03 Lescol (fluvastatin sodium) capsules, Novartis Pharmaceutical NDA 20-261/S-018 & S-022 3/8/99 6/3/99 Lescol Supplement-018provides for a new indication, the reduction of triglycerides and ApoB in patients with primary hypercholesterolemia and mixed dyslipidemia Lescol Supplement-022provides for a reduction in the recommended frequency of Liver Function Testing (LFT) and eliminates periodic, i.e., semi-annual, LFT monitoring Lescol (fluvastatin sodium) Capsules, Novartis Pharmaceutical NDA 20-261/S-024 10/23/00 11/27/00 11/27/00 Lescol Supplement-024 as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate | Lescol (fluvastatin) Capsules, Novartis Pharmaceutical NDA 20-261/S-025 12/19/00 2/20/01 | Lescol (fluvastatin) Capsules, Novartis Pharmaceutical NDA 20-261/S-30 | Lescol (fluvastatin sodium) Capsules, Novartis Pharma, Labeling Revision | Lescol XL (fluvastatin sodium) Extended-Release Tablets
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