Watson filed Sanctura XR PIV
Per Watson press release. Not a big pr0duct, but apparently good enough for Watson.
Per Watson press release. Not a big pr0duct, but apparently good enough for Watson.
Based on press release today, what is missing is 6-month stability data, rather than new clinical trials.
-- Has Tentative FDA Approval and Expects Final Approval Shortly --
LAKE FOREST, Ill., June 18 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP) , the world leader in generic injectable pharmaceuticals, today announced that the U.S. District Court for the District of New Jersey has granted summary judgment of non-infringement in Hospira's favor with regard to Sanofi Aventis' chemotherapy medicationEloxatin (R), and that Hospira has tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of the product. Hospira expects full FDA approval shortly.
1. Teva and Medicis settled Solodyn case after Teva's at-risk launch. Teva ceased shipping, was relived by Medicis from any claim, but would launch again in 2011 or earlier, under certain circumstances.