Exelbine Approval Status
FDA Approved: No
Brand name: Exelbine
Generic name: vinorelbine
Dosage form: Injectable Emulsion
Previous Name: ANX-530
Company: Adventrx Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer
Exelbine (formerly ANX-530) is a proprietary emulsion formulation of vinorelbine intended to reduce the incidence and severity of vein irritation associated with intravenous delivery of the drug. Exelbine is intended for the treatment of non-small cell lung cancer.
In August 2011, Adventrx Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Exelbine (vinorelbine) had not been approved.
Development Status and FDA Approval Process for Exelbine
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