FDA’s five criteria for assessing active ingredient sameness with respect to generic LOVENOX were also raised in a December 10th citizen petition submitted on behalf of Teva Neuroscience, Inc. (“Teva”) - http://www.hpm.com/pdf/COPAXONE%20-%203dCP.PDF - concerning FDA’s ability to approve generic versions of the company’s COPAXONE (glatiramer acetate injection), a drug product approved for the reduction of frequency of relapses in relapsing-remitting multiple sclerosis.
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