• FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix). Drug Information.
• FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic). Drug Information.
• New and Generic Drug Approvals
  • Chantix (varenicline tartrate) Tablet, Pfizer Inc., Labeling Revision
• Warning Letter: Nasim Golzar, MD

May 15, 2008

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Manual of Policies and Procedures (MaPPs) 7500.1R Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)

May 14, 2008

• Aprotinin Injection (marketed as Trasylol): Manufacturer Removes Remaining Stocks of Trasylol. FDA News and Information.
• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• Drugs@FDA Downloadable Data Files (updated)
• FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime).
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass
• New and Generic Drug Approvals
  • Cyclobenzaprine Hydrochloride Tablets, Ranbaxy, Inc., Approval
  • Definity (perflutren) Injection, Lantheus Medical Imaging, Labeling Revision
  • Flumazenil Injection, Akorn-Strides, LLC., Approval
  • Haldol (haloperidol decanoate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Haldol (haloperidol lactate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Lidocaine Hydrochloride and Epinephrine Injection, Hospira, Inc., Approval
  • Probenecid and Colchicine Tablets, Concord Laboratories, Inc., Approval
  • Ramipril Capsules, Lupin Pharmaceuticals, Inc., Tentative Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
  • Valium (diazepam) Tablets, Roche Products, Labeling Revision

May 13, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary
• New and Generic Drug Approvals
  • Ceftriaxone and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
  • Children's Cetirizine Hydrochloride Allergy Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
  • Children's Cetirizine Hydrochloride Hives Relief Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
  • Desmopressin Acetate Tablets, Ferring Pharmaceuticals, Inc., Approval
  • Drospirenone and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval
  • Emtricitabine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval
  • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • OraVerse (phentolamine mesylate) Injection, Novalar Pharmaceuticals, Inc., Approval
  • Primaxin I.M. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
  • Primaxin I.V. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
  • TACLONEX SCALP (calcipotriene and betamethasone dipropionate) Topical Suspension, Leo Pharmaceutical Products, Ltd., Approval
  • Timentin (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
  • Timentin in Plastic Container (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision

May 12, 2008

• Drug Shortage: Digitek (digoxin tablets, USP)
• FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information
• New and Generic Drug Approvals
  • Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Acarbose Tablets, Roxane Laboratories, Inc., Approval
  • Acarbose Tablets, Cobalt Laboratories, Approval
  • Actos (pioglitazone hydrochloride), Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo Research, Labeling Revision
  • Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension, Alcon, Labeling Revision
  • Calcipotriene Topical Solution, Nycomed US, Inc., Approval
  • Carboplatin Injection, EBEWE Pharma, Approval
  • Inderal (propranolol hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Inspra (eplerenone) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
  • Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Mepron (atovaquone) Suspension, GlaxoSmithKline, Labeling Revision
  • Nevanac (nepafenac) Ophthalmic Suspension, Alcon, Labeling Revision
  • Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., New or Modified Indication
  • Uroxatral (alfuzosin hydrochloride) Extended Release Tablets, Sanofi-Aventis US, LLC, Labeling Revision

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

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

May 15, 2008 Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment   May 13, 2008 Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts

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