New Drug Applications: August 2005

August 1	BioMarin Files New Drug Application for Orapred ODT
August 1	CollaGenex Pharmaceuticals Files New Drug Application for Oracea
August 2	Lilly Will Submit Arxxant to FDA in 2005
August 5	POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride)
August 8	POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine
August 10	Pfizer Submits Application for Sutent to FDA
August 14	Tercica Announces Insmed Files Citizen Petition with the FDA to Deny Approval of Increlex NDA
August 15	Discovery Labs Provides Status of Previously Submitted Response to FDA Approvable Letter for Surfaxin
August 17	Tercica Addresses Citizen Petition Filed by Insmed
August 18	Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive
August 18	Vicuron Pharmaceuticals Files New Drug Application (NDA) for Anidulafungin for Treatment of Invasive Candidiasis/Candidemia
August 19	Discovery Labs Provides Update on Status of Response to FDA Approvable Letter for Surfaxin
August 22	Neurochem Initiates Submission of NDA for Fibrillex
August 24	CTI Plans to Submit Marketing Applications for Xyotax
August 29	Femara Granted FDA Priority Review for New Indication as Adjuvant Treatment for Postmenopausal Women with Early Breast Cancer
August 30	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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New Drug Applications: August 2005

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