Omacor Data Inadequate To Support Use With Statins, FDA Says
This article was originally published in The Tan Sheet
Executive Summary
Reliant/Ross' data on combined use of its triglyceride-lowering therapy Omacor with statins were inadequate to support an indication for combination use, FDA review documents state
You may also be interested in...
GSK buying Reliant
GlaxoSmithKline gains Reliant Pharmaceuticals' cardiovascular drug portfolio, including an Rx omega-3-acid ethyl esters product, Lovaza, with its $1.65 billion acquisition of the privately held U.S. firm, according to a Nov. 21 release. Liberty Corner, N.J.-based Reliant generated net sales of $341 million from January through September 2007, a 62 percent increase from the same period in 2006, the firms say. While it is subject to Federal Trade Commission approval, the firms expect the deal to close by year-end. Reliant acquired U.S. rights to Lovaza, which was formerly known as Omacor, from Abbott Labs' Ross Products Division (1"The Tan Sheet" Nov. 29, 2004, p. 10). U.S. sales of the product increased 115 percent in the first nine months of 2007 to $206 million, according to Reliant. However, data submitted by Reliant and Ross on use of the omega-3-acid ethyl esters product along with statins were inadequate to support an indication for combination use, according to FDA (2"The Tan Sheet" March 7, 2005, p. 19)...
Abbott’s Omacor Brings Omega-3s To Rx Drug Market As Adjunct Therapy
Abbott Lab's prescription drug Omacor is the first omega-3 fatty acid product to gain FDA approval as a new molecular entity
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC