New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

July 2005

July 11

Preos New Drug Application Accepted for Review by FDA 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 Shire and Noven Resubmitted NDA for MTS, a Candidate Treatment for Pediatric ADHD Patients InKine Announces the Acceptance for Filing of Its New Drug Application (NDA) for Its Next Generation Purgative Product -- INKP-102 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 CV Therapeutics Submits Amendment to Ranexa (ranolazine) 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 Genzyme Submits BLA for Myozyme for Treatment of Pompe Disease

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