Adventrx Submits NDA

11/3/10Follow @bvbigelow

San Diego’s Adventrx Pharmaceuticals (NYSE Amex: ANX) says it has submitted a new drug application to the U.S. Food and Drug Administration for its reformulated anti-cancer drug vinorelbine injectable emulsion, (Exelbine). The FDA refused to accept the biotech’s first application after Adventrx sprang back to life in January. In a statement this morning, Adventrx CEO Brian Culley says the revised submission addresses concerns the FDA raised about its vinorelbine production by including “12 months of site-specific stability data from our intended commercial manufacturer.” Culley says Adventrx expects the application will be accepted for review in early 2011, “and we look forward to working with the Agency toward our first product approval.”

Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at bbigelow@xconomy.com or call (619) 669-8788 Follow @bvbigelow

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