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Alendronic acid/colecalciferol, sold under the brand name Fosamax Plus D among others, is a medication for the treatment of osteoporosis in men or in postmenopausal women. [ 3 ] [ 2 ] [ 4 ] [ 6 ] Alendronic acid/colecalciferol was approved for use in the United States and in the European Union in 2005.
In June 2006, Teva received from the FDA a 180-day exclusivity period to sell simvastatin (Zocor) in the U.S. as a generic drug in all strengths except 80 mg. Teva presently [when?] competes with the maker of brand-name Zocor, Merck & Co.; Ranbaxy Laboratories, which has 180-day exclusivity for the 80 mg strength; and Dr. Reddy's Laboratories ...
Simvastatin, sold under the brand name Zocor among others, is a statin, a type of lipid-lowering medication. [4] It is used along with exercise, diet, and weight loss to decrease elevated lipid levels. [4] It is also used to decrease the risk of heart problems in those at high risk. [4] It is taken by mouth. [4]
Alendronic acid, sold under the brand name Fosamax among others, is a bisphosphonate medication used to treat osteoporosis and Paget's disease of bone. [4] It is taken by mouth. [ 4 ] Use is often recommended together with vitamin D , calcium supplementation , and lifestyle changes.
ATC code C10 Lipid modifying agents is a therapeutic subgroup of the Anatomical Therapeutic Chemical Classification System, a system of alphanumeric codes developed by the World Health Organization (WHO) for the classification of drugs and other medical products.
With median follow-up of 6 years, simvastatin+ezetimibe was found to reduce the primary outcome of CV mortality, major CV event, or nonfatal stroke (34.7% vs. 32.7%; P=0.016; NNT 50 per 7 years or NNT 350 per 1 year ). There was no reduction in all-cause or CV mortality with simvastatin+ezetimibe, though there was a reduction in MI and stroke. [6]
Simvastatin: No tumorigenic effect was seen in a 72-week carcinogenicity study using mice at the low dose levels. However, at the higher dose levels (eight and 16 times the human dose equivalent), liver carcinomas and adenomas, lung adenomas, and adenomas of the Harderian gland occurred. No mutagenic effects were seen in assays.
On September 20, 2024, the United States Court of Appeals for the Third Circuit overturned that decision, holding that federal law did not block plaintiffs' state law claims against Merck over Fosamax. [186] As of June 30, 2024, about 3,115 lawsuits over Fosamax were still pending against Merck in both federal and state courts in the United States.