• BPCA/Pediatric Exclusivity Statistics (updated)
• New and Generic Drug Approvals
  • Hectorol (doxercalciferol) Capsules, Genzyme Corp., Control Supplement
• Paragraph IV Patent Certifications (updated)
• Resolved Drug Shortage: Digoxin oral tablets

July 10, 2008

• Genentech reports that it received an increased number of complaints regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. MedWatch Safety Information
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing [PDF] or [HTML]
• New and Generic Drug Approvals
  • Colazal (balsalazide disodium) Capsules, Salix Pharmaceuticals, Inc., Labeling Revision
  • EMCYT (estramustine phosphate sodium) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
  • Imuran (azathioprine) Tablets, Prometheus Laboratories, Inc., Labeling Revision
  • Imuran (azathioprine sodium) Injection, Prometheus Laboratories, Inc., Labeling Revision

July 9, 2008

• Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
• Drugs@FDA Downloadable Data Files (updated)
• FDA revises its process for responding to drug applications. FDA News
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Levoxyl (levothyroxine sodium) Tablets, King Pharmaceuticals, Inc., Labeling Revision
  • Zaditor (ketotifen fumarate) Ophthalmic Solution, Novartis Pharmaceuticals Corp., Labeling Revision
• Warning Letters
  • Clinical Investigation; Nagarjuna R. Ponugoti, M.D.
  • Clinical Investigation; Arturo Corces, M.D.
  • Clinical Investigation; Willa A. Hsueh, M.D.
  • Clinical Investigation; Nagarjuna R. Ponugoti, M.D.

July 8, 2008

• FDA issues an Information for Healthcare Professionals sheet for fluoroquinolone antimicrobial drugs. Drug Information
• New and Generic Drug Approvals
  • Abraxane (paclitaxel) I.V. Suspension, Abraxis Bioscience, Inc., Labeling Revision
  • Alocril (nedocromil sodium) Ophthalmic Solution, Allergan, Inc., Labeling Revision
  • Flovent HFA (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
  • Forteo (teriparatide [rDNA origin]) Subcutaneous Injection, Eli Lilly and Co., Control Supplement
  • Optivar (azelastine hydrochloride) Ophthalmic Solution, Meda Pharmaceuticals, Inc., Package Change
  • Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval
  • Supprelin LA (histrelin acetate) Subcutaneous Implant, Indevus Pharmaceuticals, Inc., Package Change
  • TYKERB (lapatinib ditosylate) Tablets, GlaxoSmithKline, Labeling Revision

July 7, 2008

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated)
• Heparin Screening Methods (updated)

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July 11, 2008 Federal Register: Global Harmonization Task Force, Study Groups 1 and 5; Proposed and Final Documents; Availability. Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Condoms; Availability. Federal Register: Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability. Consumer Information on: Medtronic® Attain StarFix Model 4195 Lead - P060039   July 10, 2008 Circulatory System Devices Panel Advisory Meeting, December 7-8, 2006 - Minutes Circulatory System Devices Panel Advisory Meeting, June 27, 2007 - Minutes Circulatory System Devices Panel Advisory Meeting, March 1-2, 2007 - Minutes FDA Approves New Genetic Test for Patients with Breast Cancer Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Condoms Guidance for Industry and FDA Staff - Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Transcripts   July 7, 2008 510(k) Final Decisions - June 2008 Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Agenda, Draft Roster, Final Roster, Briefing, Questions Hematology and Pathology Devices Panel Advisory Meeting, July 18, 2008 - Other

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