New Drug Applications Archive

New Drug Applications: July 2005

July 11	Preos New Drug Application Accepted for Review by FDA
July 11	Bayer and Onyx Complete Filing of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma
July 14	Encysive Announces PDUFA Date for Thelin New Drug Application in Pulmonary Arterial Hypertension
July 15	FDA Requests Additional Data on Pulminiq (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that Pulminiq is ''Approvable'' But Additional Study is Required
July 18	Upsher-Smith Laboratories Disappointed in FDA's Decision to Delay Approval of Affordable Osteoporosis Therapy
July 20	BDSI Announces Acceptance of Emezine NDA for Review By FDA
July 22	Adolor Receives FDA Approvable Letter for Entereg
July 26	Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets
July 26	Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients
July 26	InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102
July 26	Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets
July 27	Wyeth's New Drug Application for New Oral Contraceptive With Uninterrupted Dosing Regimen Accepted for Filing at FDA
July 27	CV Therapeutics Submits Amendment to Ranexa (ranolazine)
July 27	Wyeth’s NDA for New Oral Contraceptive Accepted for Filing at FDA
July 29	Discovery Labs Submits Response to FDA Approvable Letter for Surfaxin for RDS in Premature Infants
July 29	Genzyme Submits BLA for Myozyme for Treatment of Pompe Disease

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