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Exelbine FDA 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 timeline for Exelbine

Oct  3, 2011ADVENTRX Announces Results of FDA Meeting to Discuss Exelbine NDA
Aug 10, 2011Adventrx Receives Complete Response Letter for Exelbine NDA
Jan 20, 2011Adventrx Pharmaceuticals Receives PDUFA Date for Exelbine NDA
Jan  7, 2011FDA Accepts Exelbine NDA for Filing
Nov  5, 2010Adventrx Submits Exelbine New Drug Application
May  3, 2010Adventrx to Resubmit ANX-530 NDA in the Fourth Quarter of 2010
Mar 19, 2010Adventrx Receives Brand Name Acceptance for ANX-530
Mar  2, 2010Adventrx Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
Jan  6, 2010ADVENTRX Pharmaceuticals Submits ANX-530 New Drug Application

Further information

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