tag:blogger.com,1999:blog-5970824698716563441.post3538293429887428400..comments2024-03-26T11:22:58.479-04:00Comments on Strontium For Bones: Strontium And CalciumBoneLadyhttp://www.blogger.com/profile/10034636499792659801noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-5970824698716563441.post-32717916264200089172010-07-19T10:57:56.137-04:002010-07-19T10:57:56.137-04:00Dr. Bones,
"Manufacturers and distributors d...Dr. Bones,<br /><br />"Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary products they sell." This is quoted from FDA's website. Strontium citrate is a supplement.<br /><br />The FDA "expert" you quoted is misinformed about strontium malonate being an over-the-counter (OTC) preparation. Should it become available for sale, it will be a prescription drug.<br /><br />Prescription drugs need FDA approval to be sold in the U.S. Servier, the manufacturer of strontium ranelate, is not currently pursuing FDA approval to market its product. The company does not comment on future plans. Osteologix intends to file a marketing application during the first half of 2011 and to begin marketing NB S101 (strontium malonate) in the European Union in 2012. Plans for marketing in the U.S. and Japan may follow successful entry into the E.U.<br /><br />It is interesting that you quote an official from the FDA's Office of New Drugs, whose director, Dr. John Jenkins, has been in the news recently for allegedly briefing GlaxoSmithKline on the agency's internal debate about the company's diabetes drug, Avandia, which has an increased risk for heart attacks. Such conversations should never have taken place, and it makes me wonder about the leadership of the FDA. See http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?BoneLadyhttps://www.blogger.com/profile/10034636499792659801noreply@blogger.comtag:blogger.com,1999:blog-5970824698716563441.post-60997333496719939792010-07-06T14:58:02.882-04:002010-07-06T14:58:02.882-04:00I see BoneLady is now delving into facts for a cha...I see BoneLady is now delving into facts for a change so I wrote to the FDA's Office of New Drugs" to ask the FDA's opinion of strontium and it's use in the treatment of osteoporosis. Here's the statement from their chief of the Office Of New Drugs: "Despite interest in the EU, UK, and Asia for the use of strontium renelate (Protolos) and its OTC citrate and malonate analogs, neither Servier SA, nor any U.S. School Of Medicine, nor any non-profit group or manufacturer whom are financing research into alternative medical treatments of osteoporosis, have furnished the the FDA's Office Of New Drugs adequate test protocols or valid statistical, peer-reviewed studies that would merit the FDA's current recommndation NOT to include strontium in any form in it's "Notice OF New Drugs" sent to physicians monthly. <br /><br /><br />U.S. Food and Drug Administration<br />Office Of New Drugs<br />Associate Director of Pharmacology and Toxicology<br />David Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175Dr. Bonesnoreply@blogger.com