New Drug Applications Archive - July 2007
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July 2, 2007
- Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp Gel
- Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation
- Spectrum Pharmaceuticals Completes the NDA Filing for Isovorin
July 6, 2007
July 9, 2007
July 12, 2007
July 13, 2007
July 17, 2007
July 18, 2007
- Neurochem Receives Approvable Letter for Eprodisate (Kiacta) for Treatment of AA Amyloidosis
- 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
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
- New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration
July 19, 2007
- DOR BioPharma, Inc. Announces 3 Month Extension of FDA PDUFA ActionDate for orBec New Drug Application to Review Supplemental Data
- Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Acomplia/Zimulti
July 20, 2007
- Abbott Submits E.U. and U.S. Regulatory Filings for NewLower-Strength Kaletra and Aluvia (lopinavir/ritonavir) TabletSuitable for Pediatric Use in HIV/AIDS
- Biovail Provides Update on BVF-033
July 23, 2007
- IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma
- QLT Announces FDA Filing and Review of Aczone Labeling Supplement for Removal of Blood Screening Requirement
July 24, 2007
July 25, 2007
- A.T.S. Pharmaceuticals, A division of Auriga Laboratories Launches Xyralid LP Lotion
- New Study Confirms Link Between Breast Cancer and Hormone Therapy
- Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer
July 26, 2007
July 30, 2007
- GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
- D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame
