FDA accepts NDA for Exelbine for treatment of non-small cell lung cancer (NSCLC)
ADVENTRX Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for Exelbine (vinorelbine injectable emulsion or ANX-530) for the treatment of non-small cell lung cancer (NSCLC). This NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine (vinorelbine tartrate injection, from Pierre Fabre Pharmaceuticals) the reference drug. In this clinical bioequivalence study, Exelbine and the reference drug were determined by ADVENTRX to be bioequivalent.
Exelbine, an antimicrotubule agent, is an emulsion formulation of the chemotherapy drug vinorelbine.
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