FDA Gives Prescription Medication Amplify The 'OK'
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Medtronic's new spinal implant prescription medication, Amplify, was voted favorably for approval by the FDA, despite three abstaining after safety issues were raised.
The FDA's Orthopaedic and Rehabilitation Devices panel investigated data on the drug prescription that had been gathered from trials of the product, and found Amplify to be both effective and safe in patients suffering from degenerative disc disease.
About Amplify
Medtronic's new prescription drug implant, Amplify, utilizes a protein to help stimulate bone growth. The same protein is also used in Medtronic's InFuse device, a product that has already gained FDA approval and is currently used in spinal surgery procedures.
Concerns had previously been raised regarding the prescription medication, after a trial showed that 3.8% of patients had developed cancer within two years of using Amplify. However, as different forms of cancer had developed within the patients, it was deemed by the panel that Amplify was not the cause.
The Outlook on Amplify
We will continue to collaborate closely with the FDA to develop the path forward," according to Tom McGuinness, vice president and general manager of Medtronic’s biologics panel. “The potential approval of [Amplify] will further strengthen our position as the market-leading provider of a comprehensive portfolio of bone grafting options."
Currently, of Medtronic’s $15.8 billion in sales for the 2010 fiscal year, $3.5 billion has been generated from spinal products. Investors of Amplify remain “cautiously optimistic” that approval of the prescription medication implant will occur within the next six to 12 months.
