New Drug Applications Archive

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News Archive for August 2005

August 1, 2005

August 2, 2005

Lilly Will Submit Arxxant to FDA in 2005

August 5, 2005

POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride)

August 8, 2005

POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine

August 10, 2005

Pfizer Submits Application for Sutent to FDA

August 14, 2005

Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA

August 15, 2005

Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin

August 17, 2005

Tercica Addresses Citizen Petition Filed by Insmed

August 18, 2005

August 19, 2005

Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin

August 22, 2005

Neurochem Initiates Submission of NDA for Fibrillex

August 24, 2005

CTI Plans to Submit Marketing Applications for Xyotax

August 29, 2005

Femara Granted FDA Priority Review for New Indication as Adjuvant Treatment for Postmenopausal Women with Early Breast Cancer

August 30, 2005

ImClone Systems Incorporated and Bristol-Myers Squibb File Supplemental Biologics License Application for Erbitux for Treatment of Head and Neck Cancer

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