• Guidance for Industry: Individual Product Bioequivalence Recommendations 19 Newly added Bioequivalents.
• Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial)
• Drugs Shortages: Resolved Drugs Shortages: Zanosar (Streptozocin) 1gm/vial Injection
• FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information
• New and Generic Drug Approvals
  • Betamethasone Dipropionate Topical Cream, Glenmark Generics, Approval
  • Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
  • Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
  • Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Labeling Revision
  • Nabumetone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • Noroxin (norfloxacin) Tablets, Merck & Co. Inc., Labeling Revision
  • Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision
  • Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
• Office of Generic Drugs: List of Authorized Generic Drugs (updated)
• Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers (podcast)
   
• Warning and Untitled Letters
  • Adderall XR Capsules (Warning Letter)
  • Concerta (methylphenidate HCl)
  • Diovan (valsartan) Tablets
  • Focalin XR (dexmethylphenidate)
  • Methylin (methylphenidate HCl)
  • Strattera (atomoxetine HCl) (Warning Letter)

September 25, 2008

• FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers (updated)
• Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]
• International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
• New and Generic Drug Approvals
  • Amlodipine Besylate Tablets, Torrent Pharmaceuticals, Ltd., Approval
  • Carboplatin I.V. Injection, Sun Pharmaceutical Industries, Ltd., Approval
  • Nasacort AQ (triamcinolone acetonide) Nasal Spray, Sanofi-Aventis US, LLC, Patient Population Altered
  • RETROVIR (zidovudine) Capsules, GlaxoSmithKline, New Dosage Regimen
  • RETROVIR (zidovudine) Syrup, GlaxoSmithKline, New Dosage Regimen
  • RETROVIR (zidovudine) Tablets, GlaxoSmithKline, New Dosage Regimen
  • Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., New Dosage Regimen
  • Technetium Tc 99m Sestamibi (technettium tc-99m sestamibi kit) Injection, Mallinckrodt Inc., Approval
  • Ventavis (iloprost) Inhalation Solution, Actelion, Ltd., Labeling Revision

September 24, 2008

• A List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd.
• Dissolution Methods Database (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Drugs Shortages: Drugs to be Discontinued: Cefotan (cefotan injection) - updated
• Drugs Shortages: Drugs to be Discontinued: Mitozytrex (Mitomycin for Injection) - updated

September 23, 2008

• New and Generic Drug Approvals
  • AdreView (iobenguane I-123) Injection, GE Healthcare, Approval
  • Uroxatral (alfuzosin hydrochloride) Extended-Release Tablets, Sanofi-Aventis US, LLC, Labeling Revision
  • Veregen (sinecatechins) Ointment, MediGene, Inc., Labeling Revision
• Paragraph IV Patent Certifications (updated)

September 22, 2008

• FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers
• FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS). Questions and Answers

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

September 26, 2008 Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Summary Information for: NexGen LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees   September 24, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status   September 22, 2008 Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] PMA Final Decisions for August 2008   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