• Drugs Shortages: Drugs to be Discontinued; Foscavir (foscarnet sodium) injection
• Drugs Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
• New and Generic Drug Approvals
  • Diabinese (chlorpropamide) Tablets, Pharmacia & Upjohn Co., Packaging Addition
  • Glucotrol (glipizide) Tablets, Pfizer Inc., Packaging Addition
  • Glucotrol XL (glipizide) Extended-Release Tablets, Pfizer Inc., Packaging Addition
  • Glynase (glyburide) Tablets, Pharmacia & Upjohn Co., Labeling Revision
  • Ibuprofen and Diphenhydramine Citrate Tablets, Perrigo R&D Co., Tentative Approval
  • Isentress (raltegravir potassium) Tablets, Merck & Co., Inc. Labeling Revision
  • Loseasonique (levonorgestrel and ethinyl estradiol) Tablets, Duramed Pharmaceuticals, Inc., Approval
  • Micronase (glyburide) Tablets, Pharmacia & Upjohn Co., Package Change
  • Risperidone Tablets, Dr. Reddy’s Laboratories Ltd., Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Packaging Addition
  • Sutent (sunitinib malate) Capsules, Pfizer Inc., Labeling Revision 

October 30, 2008

• Drug Safety Oversight Board Meeting, October 16, 2008, Public Summary

October 29, 2008

• DDMAC Letter: Sensipar (cinacalcet) tablets
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Acanya (clindamycin phosphate and benzoyl peroxide) Gel, Dow Pharmaceutical Sciences, Inc., Approval
  • Apidra (insulin glulisine [rDNA origin]) Subcutaneous I.V. Injection, Sanofi-Aventis US, LLC, Patient Population Altered
  • ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) Sponge, Cardinal Health, Package Change
  • Cosopt (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution, Merck & Co., Inc., Labeling Revision
  • Flector (diclofenac epolamine) Patch, Institut Biochimique SA (IBSA), Labeling Revision
  • Fosrenol (lanthanum carbonate) Chewable Tablets, Shire Development Inc., Labeling Revision
  • Soma Compound with Codeine (aspirin and carisoprodol and codeiene phosphate), Tablets, Meda Pharmaceuticals, Inc., Labeling Revision
  • Trusopt (dorzolamide hydrochloride) Ophthalmic Solution, Merck & Co., Inc., Labeling Revisio
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

October 28, 2008

• Guidance for Industry: Individual Product Bioequivalence Recommendations, updated with 16 new recommendations.
• FDA issues warning letters to Bayer HealthCare for illegally marketing two unapproved drugs. FDA News
• Residual Solvents in ANDAs: Questions and Answers

October 27, 2008

• National Drug Code Directory
  • Download
  • Search
• New and Generic Drug Approvals
  • Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma, Approval
  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Pantoprazole Sodium Injection, Teva Parenteral, Tentative Approval
  • Prevacid NapraPac (lansoprazole and naproxen) Delayed-Release Capsules and Naproxen Tablets Kit, Takeda Pharmaceuticals North America, Inc., Labeling Revision
  • Promethazine Hydrochloride Injection, Wockhardt Ltd., Approval
  • Rozerem (ramelteon) Tablets, Takeda Global Research and Development Center, Inc., Efficacy Supplement with Clinical Data to Support
  • Stalevo (levodopa, carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision
  • Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval
• Pediatric Exclusivity Labeling Changes (updated)

CDER Drug Links

• Guidance

• Approved Drugs

• Approval Process

• Electronic Submissions

• Firm Registration Status

• Postmarketing Study Commitments

• Good Manufacturing Practice Regulations

• National Drug Code Directory

• MedWatch: Adverse Event Reporting

• Forms

• Presentations

• Meetings/Workshops

• Generic Drugs

• Pharmacology//Toxicology

• Small Business

• En Español

• Contact the Center for Drug Evaluation and Research

• CDER Presentations

• CDER Meetings

Hot Topics

CBER Links

• Allergenics

• Blood

• Cellular & Gene Therapy

• Devices

• Tissues

• Vaccines

• Xenotransplantation

• Consumer & Healthcare Information

• eFOIA Reading Room

• Industry

• Meetings

• Product Information

• Scientific Expertise & Research

• Guidance

• Letters to Industry

• Manufacturers Assistance

• Approvals

• Labeling

• IND Process

• Adverse Experience Reporting

• Product Deviation Reporting

• Meetings/Workshops

• Forms

• Contact the Center for Biologics Evaluation and Research

• CBER Meetings

October 31, 2008 Hematology and Pathology Devices Panel Advisory Meeting, July 18, 2008 - Transcript Class I Medical Device Recall: VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field Generator   October 30, 2008 Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008   October 27, 2008 Federal Register: Intrapartum Electronic Fetal Monitoring With Computer Assisted Diagnosis Workshop - Exploring Methods of Evaluation   News & Events • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Public Health Notifications: • Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning Class I Medical Device Recalls - • Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System   FDA Patient

Medical Device Links

• Guidance

• Industry Assistance

• Software Validation

• Design Control Guidance

• Good Manufacturing Practice/Quality Systems

• In Vitro Diagnostic Device Evaluation and Safety

• Device Advice

• Device Listing

• Establishment Registration

• Workshops and Conferences

• Advisory Meetings

• Medical Device Reporting

• Medical Device Databases

• Forms

• Contact the Center for Devices and Radiological Health

• CDRH Workshops

• CDRH Advisory Committees/Panel Meetings

• Combination Products

• Device Advice

• Electronic Submissions / eCopies

• Guidance documents

• Importing in the U.S.

• Industry Support

• International issues

• Medical device reporting (MDR)

• Getting market clearance / approval

• Ombudsman

• Standards

• STED Pilot Program

• Third party review

• Third party inspection