New!  -  US & Chinese 820 Combination Pocket Size Handbooks - Canadian GMP - Device - Clinical - Call 856-810-7331
Medical Device QSIT Handbook  -  Medical Device Quality Manuals  -  EU / US Handbooks  -  GMP Training Courses

Center for Drug Evaluation &
Research (CDER) News

• Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names [PDF]

November 20, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Drugs Shortages: Current Drug Shortages; Leucovorin
• Drugs Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials
• New and Generic Drug Approvals
  • Accutane (isotretinoin) Capsules, Hoffman La-Roche, Inc., Labeling Revision
  • Benzphetamine Hydrochloride Tablets, Impax Labs, Approval
  • Budesonide Inhalation Suspension, IVAX Pharmaceuticals, Inc., Approval
  • Emend (aprepitant) Capsules, Merck & Co., Inc., Labeling Revision
  • Ondansetron Injection, Luitpold Pharmaceuticals, Inc., Approval
  • Pepcid Complete (calcium carbonate, famotidine and magnesium hydroxide) Chewable
    Tablets, Merck & Co., Inc., Formulation Revision
  • Ranitidine Hydrochloride Tablets, Glenmark Generics Inc., USA, Approval
  • Vesicare (solifenacin succinate) Tablets, Astellas Pharma US, Inc., Labeling Revision

November 19, 2008

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Alprazolam Extended-Release Tablets, Apotex, Inc., Approval
  • Calcitonin-Salmon Nasal Spray, Apotex, Inc., Approval
  • Fluoxetine Hydrochloride Capsules, Mylan Pharmaceuticals, Inc., Approval
  • Fluoxetine Hydrochloride Capsules, Sandoz, Inc., Approval
  • Midazolam Hydrochloride Injection, Wockhardt, Ltd., Approval
  • Promethazine Hydrochloride Plain (promethazine hydrochloride) Oral Solution, ANI Pharmaceuticals, Inc., Labeling Revision
  • Triglide (fenofibrate) Tablets, SkyePharma AG, Labeling Revision
• Pharmacometrics at FDA

November 18, 2008

• CSI USA Inc. and FDA inform consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. MedWatch Safety Information
• Drugs Shortages: Resolved Drug Shortages; Argatroban Injection
• E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers [PDF]
• New and Generic Drug Approvals
  • Alfuzosin Hydrochloride Extended-Release Tablets, Aurobindo Pharma Ltd., Tentative Approval
  • Anastrozole Tablets, Stason Pharmaceuticals, Inc., Tentative Approval
  • Banzel (rufinamide) Tablets, Eisai Medical Research, Inc., Approval
  • Diclofenac Sodium Ophthalmic Solution, Apotex, Approval
  • Qualaquin (quinine sulfate) Capsules, AR Holding Co. Inc., Labeling Revision
  • Oxycodone and Acetaminophen Tablets, Coastal Pharmaceuticals, Approval
  • Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals Inc., Tentative Approval

November 17, 2008

• Guidance for Industry: Process Validation: General Principles and Practices [PDF] or [HTML]
• New and Generic Drug Approvals
  • Adderall XR (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate) Extended-Release Capsules, Shire Development, Inc., Labeling Revision
  • Alprazolam Extended-Release Tablets, Apotex Inc., Approval
  • Midazolam Hydrochloride Injection, Wockhardt Ltd., Approval
  • Phenytoin Sodium Extended-Release Capsules, Amneal Pharmaceuticals of NY, Approval
  • Promethazine Hydrochloride Syrup, ANI Pharmaceuticals, Inc., Labeling Revision
  • Spiriva (tiotropium bromide monohydrate) Inhalation Powder, Boehringer Ingelheim, Labeling Revision
  • Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Development, Inc., Labeling Revision
• Regulatory Pharmaceutical Fellowship Opportunity

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

November 21, 2008 Summary Information for: Carotid WALLSTENT Monorail Endoprosthesis Consumer Information on: Carotid WALLSTENT Monorail Endoprosthesis - P050019 Circulatory System Devices Panel Advisory Meeting, November 20, 2008 - Brief Summary General and Plastic Surgery Devices Panel Advisory Meeting, November 18-19, 2008 - Brief Summary Consumer Information on: Helios II Ablation Catheter - P050029 Summary Information for: Helios II Ablation Catheter   November 20, 2008 Class I Medical Device Recall: Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump   November 19, 2008 Federal Register: Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008 - Agenda, Roster, Briefing, Questions, Summary, Slides   November 18, 2008 Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting   November 17, 2008 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

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