Zhejiang Hisun Pharmaceutical, Co., Ltd. (Yantou Campus) Fails EDQM Inspection
Teva Pharma USA`s Generic Fluvastatin Sodium approved in US for lowering cholesterol
Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Fluvastatin Sodium Extended-release Tablets, 80 mg, which is the generic version of Novartis' Lescol XL® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride, and increase HDL-C in adults with primary hypercholesterolaemia and mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.