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Center for Drug Evaluation &
Research (CDER) News

• FDA Public Health Advisory Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammography and Other Medical Tests and Conditions. Information
• Guidance for Industry:
  • Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF]
  • Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act [PDF]
• National Drug Code Directory
• New and Generic Drug Approvals
  • Amoxicillin Tablets, DAVA Pharmaceuticals, Inc., Approval
  • Levetiracetam Oral Solution, Roxane Laboratories, Inc., Approval
  • Levetiracetam Oral Solution, TOLMAR Inc., Approval
  • Levetiracetam Tablets, Aurobindo Pharma, Inc., Approval
  • Levetiracetam Tablets, Cobalt Laboratories, Inc., Approval
  • Levetiracetam Tablets, Dr. Reddy’s Laboratories Limited, Approval
  • Levetiracetam Tablets, Lupin Limited, Approval
  • Levetiracetam Tablets, Orchid Healthcare, Approval
  • Levetiracetam Tablets, Roxane Laboratories, Inc., Approval
  • Levetiracetam Tablets, Sandoz Inc., Approval
  • Levetiracetam Tablets, Torrent Pharmaceuticals Limited, Approval

January 15, 2009

• Adverse Event Reporting System (AERS) Statistics
  (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA Drug Safety Newsletter, Volume 2, Number 1, 2009
• New and Generic Drug Approvals
  • Cefpodoxime Proxetil Oral Solution, Sandoz Inc., Approval
  • Savella (milnacipran hydrochloride) Tablets, Forest Laboratories, Inc., Approval

January 14, 2009

• Guidance for Industry:
  • Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection [PDF] or [HTML]
  • Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S.[HTML]
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Meeting Summary: Drug Safety Oversight Board Off-Site, December 18, 2008
• New and Generic Drug Approvals
  • Folic Acid Tablets, Excellium Pharmaceutical, Inc., Approval
  • Humatrope (somatropin [rDNA origin]) Injection, Eli Lilly and Co., Control Supplement
  • Isentress (raltegravir potassium) Tablets, Merck & Co., Inc., Labeling Revision
  • Lithium Carbonate Capsules, Kendle Regulatory Affairs, Approval
  • Survanta (beractant) Intratracheal Suspension, Abbott Laboratories, Labeling Revision

January 13, 2009

• BPCA/Pediatric Exclusivity Statistics (updated)
• Drugs Shortages: Resolved Drug Shortages; Albuterol Metered Dose Inhalers and Levalbuterol Metered Dose Inhalers
• Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Montelukast (Singulair) Information
• Inactive Ingredient Search for Approved Drug Products (updated)
• New and Generic Drug Approvals
  • Alprazolam Orally Disintegrating Tablets, Kali Laboratories, Inc., Approval
  • Venlafaxine Hydrochloride Tablets, Actavis Totowa LLC, Approval
  • Zingo (lidocaine hydrochloride) Intradermal System, Anesiva, Inc., Patient Population Altered
• Office of Generic Drugs: List of Authorized Generic Drugs (updated)

January 12, 2009

• The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated)
• CDER Organization Charts [HTML] [PDF] (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

CDER Drug Links

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• Contact the Center for Drug Evaluation and Research

• CDER Presentations

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January 15, 2009
	Federal Register: Institutional Review Boards; Registration Requirements
	Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, December 9, 2008 - Transcript
	Federal Register: Unique Device Identification System; Public Workshop; Request for Comments
January 14, 2009
	FDA Unique Device Identification Public Workshop: February 12, 2009
January 13, 2009
	Federal Register: Advisory Committees; Tentative Schedule of Meetings for 2009
	Federal Register: Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability
January 12, 2009
	Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Transcript
	Immunology Devices Panel Advisory Meeting, December 3, 2008 - Transcript
	Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008 - Transcript

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