• CDER Organization Charts [HTML] [PDF] (updated)
• New and Generic Drug Approvals
  • Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
    Extended-Release Tablets, Sandoz Inc., Approval
  • Fomepizole Injection, Navinta LLC, Approval
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Olmesartan Medoxomil Tablets, Mylan Pharma, Tentative Approval
  • Pexeva (paroxetine mesylate) Tablets, AAC/Kendle Consulting, Labeling Revision
  • Promethazine Hydrochloride Tablets, Actavis Totowa, Approval
  • Rapamune (sirolimus) Oral Solution, Wyeth Pharma, Labeling Revision
  • Rapamune (sirolimus) Tablets, Wyeth Pharma, Labeling Revision
  • Zoloft (sertraline hydrochloride) Tablets, Pfizer Pharma, Labeling Revision
  • Zoloft (sertraline hydrochloride) Oral Concentrate, Pfizer Pharma, Labeling Revision

March 6, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA releases information on two tests that manufacturers and regulators can use to screen heparin for contaminants.
• Guidance for Industry: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route [PDF] or [HTML]
• New and Generic Drug Approvals
  • Alendronate Sodium Tablets, Apotex, Tentative Approval
  • Gemcitabine Injection, Sun Pharma, Tentative Approval
  • Octreotide Acetate Injection, Sun Pharma, Approval
  • Premarin (conjugated estrogens) Tablets, Wyeth Pharma, Labeling Revision
  • Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharma, Labeling Revision
  • Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets, Wyeth Pharma, Labeling Revision
  • Sandostatin LAR Depot Injection (octreotide acetate), Novartis Pharma, New or Modified Indication
  • Ventavis (iloprost) Inhalation Solution, Actelion Clinical Research, Labeling Revision

March 5, 2008

• Cyber Letters (updated)
• FDA updates safety information for long acting beta agonists (LABA).
• National Drug Code Directory Download (updated)
• National Drug Code Directory Search (updated)
• New and Generic Drug Approvals
  • Aloxi (palonosetron hydrochloride) Intravenous Injection, Helsinn Healthcare, Efficacy Supp. w/Clinical Data to Support and New or Modified Indication
  • Efavirenz Tablets, Hetero Drugs Ltd, Tentative Approval
  • Escitalopram Oxalate Tablets,Watson Labs, Tentative Approval
  • Fenoglide (fenofibrate) Tablets, Sciele Pharma, Labeling Revision
  • Fomepizole Injection, Synerx Pharma, Approval
  • Sodium Iodide I 131 Capsules and Solution, Draximage, Labeling Revision
  • OPANA ER (oxymorphone hydrochloride) Extended-Release Tablets, Endo Pharma, Manufacturing Change or Addition
  • Penicillin G Potassium Injection, Baxter Healthcare, Labeling Revision
  • Premarin Intravenous (conjugated estrogens) Injection, Wyeth Pharma, Labeling Revision
  • Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca, Package Change
  • Pristiq (desvenlafaxine succinate) Extended Release Tablets, Wyeth Pharma, Approval
  • Tarka (trandolapril/verapamil hydrochloride) Extended Release Tablets, Abbott Labs, Labeling Revision
  • Telmisartan Tablets, Watson Labs, Tentative Approval
  • Zavesca (miglustat) Capsules, Actelion Clinical Research, Labeling Revision

March 4, 2008

• Drug Safety Oversight Board Meeting, February 21, 2008, Public Summary
• Drug Shortages: Fentanyl transdermal patch (updated
• Manuals of Policies and Procedures (MaPPs)
  • Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) [PDF]
  • Management of the PTCC Reproductive and Developmental Toxicology Subcommittee [PDF]
• New and Generic Drug Approvals
  • Amlodipine Besylate and Benazepril Hydrochloride Capsules, Kali Labs, Tentative Approval
  • ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Labeling Revision
  • Forteo (teriparatide) 3ml Cartridge, Eli Lilly & Co., Labeling Revision
  • Granisetron Hydrochloride Injection, Wockhart, Approval
  • Granisetron Oral Solution, Cypress Pharma, Approval
  • Imipramine Hydrochloride Tablets, Actavis Totowa, Approval
  • Luvox CR (fluvoxamine maleate) Extended-Release Capsules, Solvay Pharma, Approval
  • Sensipar (cinacalcet HCl) Tablets, Amgen Inc., Labeling Revision
  • Stavudine Capsules, Hetero Drugs Limited, Tentative Approval
  • Tylenol 8-Hour (acetaminophen) Extended-Release Tablets and Tylenol Arthritis Pain (acetaminophen) Extended-Release Tablets, McNeil Consumer, Labeling Revision
• Correction: The application for Risperidone Tablets from Ranbaxy was incorrectly listed as approved in Drugs@FDA. This application is not approved. We have corrected Drugs@FDA.
   

March 3, 2008

• Drug Shortages:
  • Fentanyl transdermal patch
  • Heparin sodium injection multidose and single dose vials, heparin flush products from Baxter

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March 7, 2008 Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Brief Summary   March 5, 2008 510(k) Final Decisions - February 2008 Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)   March 3, 2008 Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff

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