New Drug Applications: July 2007

July 2	Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp Gel
July 2	Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation
July 2	Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
July 6	Wyeth to File for FDA Approval of Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
July 9	MGI Pharma and Helsinn Announce Aloxi sNDA for PONV Accepted for Review By U.S. FDA
July 12	Sucampo Pharmaceuticals Submits Supplemental New Drug Application for Lubiprostone to Treat Irritable Bowel Syndrome With Constipation
July 13	Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)
July 17	Salix Pharmaceuticals Announces Submission of Balsalazide Tablet New Drug Application
July 18	Abilify (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder
July 18	Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
July 18	U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
July 18	New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration
July 19	DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA Action Date for orBec New Drug Application to Review Supplemental Data
July 19	Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti
July 20	Abbott Submits E.U. and U.S. Regulatory Filings for New Lower-Strength Kaletra and Aluvia (lopinavir/ritonavir) Tablet Suitable for Pediatric Use in HIV/AIDS
July 20	Biovail Provides Update on BVF-033
July 23	IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma
July 23	QLT Announces FDA Filing and Review of Aczone Labeling Supplement for Removal of Blood Screening Requirement
July 24	Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause
July 25	A.T.S. Pharmaceuticals, A division of Auriga Laboratories Launches Xyralid LP Lotion
July 25	New Study Confirms Link Between Breast Cancer and Hormone Therapy
July 25	Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer
July 26	Kuvan Receives Priority Review Status from FDA
July 30	GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
July 30	D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame
July 31	Lev Pharmaceuticals Submits Biologics License Application for Cinryze

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New Drug Applications: July 2007

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