• FDA updates healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents. Drug Information
• New and Generic Drug Approvals
  • Doxycycline Oral Suspension, IVAX Pharmaceuticals, Inc., Approval
  • Indomethacin Sodium Injection, Bedford Laboratories, Approval
• Roxane Laboratories informs healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, a product used to treat hyperkalemia. MedWatch Safety Information

July 16, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
• New and Generic Drug Approvals
  • FazaClo ODT (clozapine) Orally Disintegrating Tablets, Beckloff Associates, Inc., Labeling Revision
  • Meloxicam Tablets, Beijing Double-Crane Pharmaceutical Co., Ltd., Supplement
  • Starlix (nateglinide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca Pharmaceuticals, Labeling Revision
• Obtaining an IND for Estriol

July 15, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Levoleucovorin (levoleucovorin calcium) I.V. Powder, Spectrum Pharmaceuticals, Inc., Labeling Revision
  • Prandin (repaglinide) Tablets, Novo Nordisk, Inc., Labeling Revision
  • Synthroid (levothyroxine sodium) Tablets, Abbott Laboratories, Labeling Revision

July 14, 2008

• Genentech informs healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. MedWatch Safety Information
• Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs [PDF]
• New and Generic Drug Approvals
  • Avandia (rosiglitazone maleate) Tablets, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support

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July 17, 2008 FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 (Video Added)   July 16, 2008 Summary Information for: EVOLENCE Collagen Filler Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary PMA Final Decisions for June 2008   July 14, 2008 FDA Preliminary Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning

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