Updates: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 24 May 2008 12:03:37 -0500 (CDT)
Subject: CDER New 5/22 & 23/2008
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May 23, 2008
- New and Generic Drug Approvals
- Cyclophosphamide Injection, Baxter Healthcare Corp., Approval
- EES (erythromycin ethylsuccinate) Chewable Tablets, Abbott Laboratories, Labeling Revision
- EES (erythromycin ethylsuccinate) Oral Granules, Abbott Laboratories, Labeling Revision
- Eloxatin (oxaliplatin) Injection, Sanofi-Aventis US, Inc., Labeling Revision
- Eloxatin (oxaliplatin) Injection, Sanofi-Aventis US, Inc., Efficacy Supplement with Clinical Data to Support
- EryPed (erythromycin ethylsuccinate) Chewable Tablets, Abbott Laboratories, Labeling Revision
- EryPed (erythromycin ethylsuccinate) Oral Granules, Abbott Laboratories, Labeling Revision
- Fluoxetine (fluoxetine hydrochloride) Capsules, Teva Pharmaceuticals USA, Approval
- Granisetron Hydrochloride Injection, Ebewe Pharmaceuticals, Inc., Tentative Approval
- Milrinone Lactate in Dextrose 5% in Plastic Container Injection, Bedford Laboratories, Inc., Approval
- PCE (erythromycin) Tablets, Abbott Laboratories, Labeling Revision
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
- PDUFA Pilot Project - Proprietary Name Review: Draft Concept Paper
- Paragraph IV Patent Certifications (updated)
May 22, 2008
- New and Generic Drug Approvals
- Biaxin (clarithromycin) Tablets, Abbott Laboratories, Labeling Revision
- Biaxin (clarithromycin) Oral Suspension, Abbott Laboratories, Labeling Revision
- Biaxin XL (clarithromycin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
- Keflex (cephalexin) Capsules, Lex Pharmaceuticals, Inc., Labeling Revision
- Noxafil (posaconazole) Oral Suspension, Schering Corp., Labeling Revision
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