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April 1, 2008

• International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information
• New and Generic Drug Approvals
  • Avodart (dutasteride) Soft Gelatin Capsule, GlaxoSmithKline, Labeling Revision
  • ANTHELIOS 40 (avobenzone, ecamsule, octocrylene and titanium dioxide) Cream, Loreal, Approval
  • Hydroxyzine Hydrochloride Tablets, Northstar Healthcare, Approval
  • Metronidazole in Plastic Container Injection, Claris LifeSciences, Approval
  • Xyzal (levocetirizine dihydrochloride) Tablets, UCB Inc., Labeling Revision
• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft)
• Warning Letter: Inspection; West Jefferson Medical Center IRB

March 31, 2008

• Guidance for Industry: Comprehensive List of Guidance Documents and New/Revised/Withdrawn List for 2008
• New and Generic Drug Approvals
  • AMOXIL (amoxicillin) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Tablets, Capsules, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Lamotrigine Tablets, Taro Pharma, Tentative Approval
  • Primaxin I.V. (Imipenem and Cilastatin) Injection, Merck & Co., Labeling Revision
  • Primaxin I.M. (Imipenem and Cilastatin) Injectable Suspension, Merck & Co., Labeling Revision
  • Rifampin Capsules, Lannett, Approval

March 28, 2008

• New and Generic Drug Approvals
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN (amoxicillin/clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
  • Bethanechol Chloride Tablets, Lannett, Approval
  • Merrem I.V.(meropenem) Injection, AstraZeneca Pharma, Labeling Revision

March 27, 2008

• Add a widget to your Web site; insert links to FDA content into your own Web pages.
• FDA issues a Communication about an Ongoing Safety Review of Regranex (marketed as Becaplermin).
• FDA issues an Early Communication about an Ongoing Safety Review of Ziagen (marketed as Abacavir) and Videx (marketed as Didanosine).
• FDA issues an Early Communication about an Ongoing Safety Review of Montelukast (marketed as Singulair).
• New and Generic Drug Approvals
  • Cefprozil Tablets, Apotex, Approval
  • Fenofibrate Tablets, IMPAX Labs, Approval
  • REYATAZ (atazanavir sulfate) Capsules, Bristol-Myers Squibb, Patient Population Altered
  • Ventolin HFA (albuterol sulfate) Inhalation Aerosol, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support

March 26, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA releases information on Risk Evaluation and Mitigation Strategies (REMS).
• Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF]
• New and Generic Drug Approvals
  • AMRIX (cyclobenzaprine  hydrochloride) Extended-Release Capsules, Anesta AG, Labeling Revision
  • Depakote (divalproex sodium) Sprinkle Capsules, Abbott Labs, Patient Population Altered
  • Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Labs, Patient Population Altered
  • INVANZ (ertapenem sodium) Injection, Merck & Co., Labeling Revision
  • Tigan (trimethobenzamide hydrochloride) Capsules, King Pharma, Labeling Revision
• Warning Letters
  • Avinza, King Pharmaceuticals, Inc.
  • Inspection, Coast Institutional Review Board

March 24, 2008

• Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF]
• On March 21, 2008, B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). MedWatch Safety Information
• New and Generic Drug Approvals
  • Fioricet w/Codeine Capsules, Watson Labs, Labeling Revision
  • Gabapentin Tablets, Zydus Pharma, Tentative Approval
  • Glycopyrrolate Tablets, Indicus Pharma, Approval
  • Ondansetron Injection, Taro Pharma, Approval
  • Phentermine Hydrochloride Capsules, KVK-Tech, Approval
  • Prozac (fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision
  • Prozac (fluoxetine HCl) Solution, Eli Lilly & Co., Labeling Revision
  • Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly & Co., Labeling Revision
  • Stavudine/Lamivudine/Nevirapine Tablets, Strides Arcolab, Tentative Approval
  • Symbyax (olanzapine/fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision
  
  

March 21, 2008

• Drug Shortages
  • Current Drug Shortage: Heparin (updated)
  • Resolved Drug Shortage: Levothyroxine sodium lyophilized powder for injection
• FDA issues an FDA Alert and Information for Healthcare Professionals Sheet for Prezista (darunavir ethalolate).
• New and Generic Drug Approvals
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
  • Butalbital, Aspirin and Caffeine Capsules, Mutual Pharma, Labeling Revision
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution, Mallinckrodt Inc., Control Supplement
  • Hydrocodone Bitartrate and Acetaminophen Tablets, Watson Labs, Manufacturing Revision
  • Metoprolol Succinate Extended-Release Tablets, KV Pharma, Approval
  • Oxycodone and Acetaminophen Tablets, Watson Labs, Package Change
  • Ribavirin Tablets, Zydus Pharma, Packaging Addition
  • Ribavirin Tablets, Sandoz Inc., Control Supplement
  • Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
  • Zometa (zoledronic acid) Injection, Novartis Pharma, Patient Population Altered
    
• Paragraph IV Patent Certifications (updated)

March 20, 2008

• New and Generic Drug Approvals
  • Cefepime Hydochloride Injection, ACS Dobfar, Approval
  • Levitra (vardenafil hydrochloride) Tablets, Bayer Healthcare, Inc., Labeling Revision
  • TREANDA (bendamustine hydrochloride) Injection, Cephalon, Approval
    

March 19, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Benzonatate Capsules, Sun Pharmaceutical Industries, Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Baxter Healthcare, Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Bedford Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Claris Lifesciences Ltd., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hospira Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Sagent Pharmaceuticals, Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Teva Parenteral Medicines, Inc, Approval
  • Divalproex Sodium Delayed Release Tablets, Zydus Pharmaceuticals, Tentative Approval
  • Fosphenytoin Sodium Injection, Akorn-Strides, LLC, Approval
  • Fosphenytoin Sodium Injection, Sun Pharmaceutical Industries, Inc., Approval
  • Rizatriptan Benzoate Orally Disintegrating Tablets, Mylan Pharmaceuticals, Tentative Approval
  • Symbyax (fluoxetine hydrochloride; olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
    

March 18, 2008

• FDA issues an Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler).
• FDA releases its second issue of the FDA Drug Safety Newsletter.
• FDA releases a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program.
• New and Generic Drug Approvals
  • Isosorbide Dinitrate Extended-Release Tablets, CorePharma, Approval
  • Morphine Sulfate Oral Solution, Roxane Labs, Approval
  • Morphine Sulfate Tablets, Roxane Labs, Approval
  • NASAREL (flunisolide) Spray Metered, IVAX Research, Manufacturing Change or Addition
  • Ofloxacin Otic Solution, Alcon, Approval
  • Ofloxacin Otic Solution, Bausch & Lomb, Approval
  • Ofloxacin Otic Solution, Hi-Tech, Approval
  • Ondansetron Hydrochloride and Dextrose in Plastic Container Injection, Claris Lifesciences, Approval
    

March 17, 2008

• New and Generic Drug Approvals
  • ACZONE (dapsone) Gel, QLT Inc., Efficacy Supp. w/Clinical Data
  • Amifostine Injection, Sun Pharma, Approval
  • Azmacort (triamcinolone acetonide) Inhalation Aerosol, Abbott Labs, Labeling Revision
  • Bupropion Hydrochloride Extended-Release Tablets, Actavis, Approval
  • FLOLAN (epoprostenol sodium) Injection, GlaxoSmithKline, Labeling Revision
  • Granisetron Hydrochloride Injection, Wockhardt, Tentative Approval
  • Hydroxyzine Hydrochloride Tablets, InvaGen Pharma, Approval
  • MERREM I.V. (meropenem) Injection, AstraZeneca, Labeling Revision
  • Moban (molindone hydrochloride) Tablets, Endo Pharma, Labeling Revision
  • NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Patient Population Altered
  • Paroxetine Hydrochloride Tablets, Mylan Pharma, Approval
  • SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Manufacturing Change or Addition
  • Tramadol Hydrochloride Tablets, Pliva Inc., Control Supplement
    
  • Tramadol Hydrochloride Tablets, Pliva Inc., Facility Addition
  • Tramadol Hydrochloride Tablets, Pliva Inc., Manufacturing Revision
    
• Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop.

March 13, 2008

• New and Generic Drug Approvals
  • Minocycline Hydrochloride Capsules, Aurobindo Pharma, Approval
  • Monurol (fosfomycin tromethamine) Zambon, Labeling Revision
  • Paclitaxel Injection, PLIVA, Approval
  • Septra (sulfamethoxazole; trimethoprim) Tablets, and Septra DS (sulfamethoxazole; trimethoprim) Tablets, Monarch Pharms, Labeling Revision
  • Septra (sulfamethoxazole; trimethoprim) Suspension, Monarch Pharms, Labeling Revision
  • Septra (sulfamethoxazole; trimethoprim) I.V., Monarch Pharms, Labeling Revision
  • Tobramycin (tobramycin sulfate) Injection, Akorn-Strides, Approval
  • Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension, UCB Inc., Labeling Revision
  • Urex (methenamine hippurate) Oral Tablets, Vatring Pharms, Labeling Revision
  • Urso Forte (ursodiol, USP) Tablets, Axcan Scandipharm, Package Change
  • VFEND (voriconazole) Tablets, Pfizer Inc., Labeling Revision
  • VFEND (voriconazole) I.V. for Injection, Pfizer Inc., Labeling Revision
  • VFEND (voriconazole) for Oral Suspension, Pfizer Inc., Labeling Revision
• Amgen and FDA notify healthcare professionals of changes to the Boxed Warnings/Warnings for increased mortality and/or tumor progression section of the Aranesp and Epogen/Procrit labeling. MedWatch Information
• Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book
• Dissolution Methods Database (updated)
• Drug Approval Reports
  • NDA and BLA Approvals (updated)
  • NME Drug and New Biologic Approvals (updated)
  • Priority NDA and BLA Approvals (updated)
• FDA and Tibotec Therapeutics notify healthcare professionals of changes to the Warnings section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. MedWatch Information

March 12, 2008

• New and Generic Drug Approvals
  • Clobetasol Propionate Foam, Perrigo, Approval
  • Levoleucovorin Injection, Spectrum Pharms, Approval
  • Prozac (fluoxetine HCl) Capsules, Eli Lilly and Co., Labeling Revision
  • Prozac (fluoxetine HCl) Oral Solution, Eli Lilly and Co., Labeling Revision
  • Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly and Co., Labeling Revision
  • Rosiglitazone Maleate Tablets, Roxane Labs, Tentative Approval
• BPCA/Pediatric Exclusivity Statistics:
• Written Requests Issued (updated)
• Written Requests Statistics (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML]
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Office of Generic Drugs: February First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)

March 11, 2008

• FDA updates screening method for heparin: Impurity Evaluation of Heparin Sodium by ¹H-NMR Spectroscopy
• FDA issues an Information for Healthcare Professionals sheet and Public Health Advisory for Tussionex Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing cough product. Drug Information
• FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop April 29, 2008. Meeting Information

March 10, 2008

• New and Generic Drug Approvals
  • Abilify (aripiprazole) Tablets, Otsuka, Labeling Revision
  • Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Oral Solution, Otsuka, Labeling Revision
  • Abilify (aripiprazole) Injection, Otsuka, Labeling Revision
  • Nabumetone Tablets, InvaGen Pharma, Approval
  • Ponstel (mefenamic acid) Capsules, Sciele Pharma, Labeling Revision
  • Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Assoc., Approval
  • Prezista (darunavir ethanolate) Tablets, Tibotec Inc., Labeling Revision
  • Singulair (montelukast sodium) Tablets, Merck and Co., Labeling Revision
  • Singulair (montelukast sodium) Chewable Tablets, Merck and Co., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck and Co., Labeling Revision

March 7, 2008

• 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

February 29, 2008

• CDER Key Officials
• Drug Shortage
  • Drug to be Discontinued: Enlon (edrophonium chloride) injection and Enlon Plus (edrophonium chloride and atropine sulfate) injection
• FDA issues a Public Health Advisory highlighting the correct use of Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) capsules.
• Guidance for Industry: Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention [PDF] or [HTML]
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

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