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What's New by Date

This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version. 

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October 29. 2004

October 28, 2004

October 27, 2004

  • New and Generic Drug Approvals
    • Amphadase (hyaluronidase injection, USP), Amphastar Pharma, Approval
    • Axid AR (nizatidine) Tablets, Wyeth Consumer, Labeling Revision
    • Cuprimine (penicillamine) Capsules, Merck & Co., Inc., Labeling Revision
    • Finasteride Tablets, Teva Pharmaceuticals, Tentative Approval
    • FOSRENOL (lanthanum carbonate) Chewable Tablets, Shire Pharma, Approval
    • Keppra (levetiracetam) Tablets, UCB Pharma, Inc., Labeling Revision
    • Keppra (levetiracetam) Oral Solution, UCB Pharma, Inc., Labeling Revision
    • (Lidocaine HCl 2% and Epinephrine 1:100,000 Solution for Topical Iontophoretic System), Empi, Inc., Approval
    • Medroxyprogesterone Acetate Injectable Suspension, Sicor Pharma, Approval

October 26, 2004

  • FDA, Janssen Pharmaceutica Products, and Johnson & Johnson Pharmaceutical Research & Development notify healthcare professionals of reports of medication errors involving confusion between Reminyl and Amaryl (glimepiride). MedWatch Safety Info.
  • Inactive Ingredient Database

October 25, 2004

October 22, 2004

October 21, 2004

October 20, 2004

  • New and Generic Drug Approvals
    • Allegra-D 24 Hour Extended-Release Tablets, Aventis Pharma, Approval
    • KALETRA (Lopinavir/Ritonavir) capsules, Global Pharma, Efficacy Supplement with Clinical Data to Support
    • KALETRA (Lopinavir/Ritonavir) oral solution, Global Pharma, Efficacy Supplement with Clinical Data to Support
    • Metolazone Tablets, Mylan Pharma, Chemistry New Strength
    • Torsemide Tablets, Pliva Pharma, Chemistry New Strength

October 19, 2004

  • New and Generic Drug Approvals
    • Alocril (nedocromil sodium ophthalmic solution), Allergan, Package Change & Labeling Revision
    • Aricept (donepezil HCl) Oral Solution, Eisai Medical Research, Approval
    • Aricept (donepezil HCl) Orally Disintegrating Tablet, Eisai Medical Research, Approval
    • Cefazolin Injection, Hikma Farmaceutica, Approval
    • Cefuroxime Axetil Tablets, Teva Pharma, Approval
    • Gabapentin Capsules, Watson Labs, Tentative Approval
    • LUPRON (leuprolide acetate) Injection, TAP Pharma, Labeling Revision

October 18, 2004

October 15, 2004

October 14, 2004

  • New and Generic Drug Approvals
    • Carboplatin Injection, Bedford Labs, Approval
    • Carboplatin Injection, Mayne Pharma, Approval
    • Carboplatin Injection, Pharmachemie, Approval
    • Carboplatin Injection, American Pharmaceutical Partners, Approval
    • Finasteride Tablets, Dr. Reddy’s Labs, Tentative Approval
    • Metformin Hydrochloride Extended-Release Tablets, Eon Labs, Tentative Approval
    • Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharma, Labeling Revision
    • Septocaine (articaine HCl 4% w/epinephrine 1:100,000) Injection, Deproco, Inc., Labeling Revision
  • FDA approves four first-time generics for Carboplatin for initial and secondary treatment of advanced ovarian cancer. The reference listed drug is Paraplatin.

October 13, 2004

  • Cyber Warning Letters for June and September, 2004

  • FDA and Centocor notify healthcare professionals of revisions to the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies of all TNFα-blocking agents, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients. MedWatch Safety Info.

  • New and Generic Drug Approvals
    • Imitrex (sumatriptan) nasal spray, GlaxoSmithKline, Patient Population Altered
    • Norditropin Cartridges (somatropin rDNA origin) Injection, Novo Nordisk, New or Modified Indication
    • Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo, Labeling Revision

October 12, 2004

October 8, 2004

  • Biogen Idec and Genentech notify healthcare professionals of revisions to the prescribing section of the Rituxan (rituximab) label due to reports of Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death in some patients with hematologic malignancies. MedWatch Safety Info.
  • Drug Master Files (updated)
  • FDA approves first-time generic Gabapentin for adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy. The reference listed drug is Neurontin.
  • Investigational Human Drugs: Clinical Investigator Inspection List (updated)
  • New and Generic Drug Approvals
    • Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
    • Diflucan (fluconazole) Injection, Pfizer, Inc., Labeling Revision
    • Diflucan (fluconazole) Powder, Pfizer, Inc., Labeling Revision
    • Gabapentin Capsules, Teva Pharma, Approval
    • Luveris 75 IU (lutropin alfa for injection), Serono, Approval
    • SORIATANE (acitretin) Capsules, Connetics, Labeling Revision

October 7, 2004

October 6, 2004

October 5, 2004

October 4, 2004

October 1, 2004

  • New and Generic Drug Approvals
    • BSS (balanced salt solution) Sterile Irrigating Solution, Alcon Laboratories, Labeling Revision
    • Mefloquine Hydrochloride Tablets, Roxane Labs, Approval
    • Metformin Hydrochloride Extended-release Tablets, Purepac Pharma, Approval
    • Monistat 1 Combination Pack, Personal Products, New Dosage Regimen
    • NeoTect (Kit for the Preparatio n of Technetium Tc99m Depreotide Injection), Berlex, Formulation Revision
    • Norditropin NordiFlex (somatropin [rDNA origin] injection), Novo Nordisk, Package Change
  • Preparation for International Conference on Harmonization Meetings in Yokohama, Japan October 19, 2004, Rockville, MD. Meeting Information.

September 30, 2004

September 29, 2004

  • Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products. Federal Register notice [HTML] or  [TXT] or [PDF
  • Drug Shortage: Resolved; Duragesic (fentanyl transdermal system)
  • FDA issues the final report on its 21st Century Initiative on the Regulation of Pharmaceutical Manufacturing. FDA News. Final Report.
  • New and Generic Drug Approvals
    • (Amlexanox) Mucoadhesive Patch, Pharmaceuticals, Approval
    • Abilify (aripiprazole) Tablets, Otsuka Maryland Research, New or Modified Indication
    • Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision
    • Aranelle (Norethindrone & Ethinyl Estradiol) Tablets, Barr Laboratories, Approval
    • Caduet (amlodipine besylate/atorvastatin calcium) Tablets, Pfizer Inc., Supplement
    • Cleocin HCl (clindamycin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
    • Cleocin Phosphate (clindamycin injection, USP) Sterile Solution, Pfizer, Inc., Labeling Revision
    • Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution, Pfizer, Inc., Labeling Revision
    • Clorazepate Dipotassium Tablets, Ranbaxy Labs, Approval
    • Dexrazoxane Injection, Bedford Labs, Approval
    • Haloperidol Injection, Sabex 2002 Inc., Approval
    • Oxycodone Hydrochloride Extended-Release Tablet(80mg), Endo Pharma, Approval
    • Pamidronate Disodium Injection, Bedford Laboratories, Manufacturing Change or Addition
    • Remicade (infliximab) for IV Injection, Centocor, Prior Approval Efficacy Supplement - Expanded Indication
    • Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision
  • Pharmaceutical Good Manufacturing Practices Guidances
    • Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations [HTML] - [PDF] - [Word]
    • Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [HTML] - [PDF] - [Word]

    • Guidance for Industry: and FDA — Current Good Manufacturing Practice for Combination Products [HTML] - [PDF] - [Word]

    • Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] - [PDF] - [Word]
    • Draft Guidance for Industry Computerized Systems Used in Clinical Trials [HTML] - [PDF] - [Word]

September 28, 2004

September 27, 2004

September 24, 2004

September 23, 2004

  • New and Generic Drug Approvals
    • Aromasin (exemestane tablets), Pfizer Inc., Labeling Revision
    • CANASA (mesalamine) Suppository, Axcan Scandipharm, Labeling Revision
    • Ciprofloxacin Injection, Bedford Labs, Tentative Approval
    • Diuril (chlorothiazide) Tablets Merck & Co., Inc, Labeling Revision
    • Diuril (chlorothiazide) Intravenous Injection Merck & Co., Inc, Labeling Revision
    • Diuril (chlorothiazide) Oral Suspension Merck & Co., Inc, Labeling Revision
    • Ibuprofen Oral Suspension, Perrigo R & D, Approval

September 22, 2004

September 21, 2004

  • New and Generic Drug Approvals
    •  Cetirizine Hydrochloride Tablets, Teva Pharma, Tentative Approval
    • Exelon (rivastigmine) capsules, Novartis Pharma, Labeling Revision
    • Exelon (rivastigmine) oral solution, Novartis Pharma, Labeling Revision
    • Gabapentin Capsules, Mutual Pharmaceutical, Tentative Approval
    • Indium DTPA (Pentetate Indium Disodium In 111), GE Healthcare, Labeling Revision
    • Levocarnitine Tablets, CorePharma, Approval
    • Milrinone Lactate Injection, Apotex Corp., Approval
    • Rilutek (riluzole) tablets, Aventis Pharma, Labeling Revision
    • Teril (Carbamazapine) Oral Suspension, Taro Pharma, Approval

September 20, 2004

September 17, 2004

  • Drug Shortage: Discontinuation; Agenerase (amprenavir) 150mg capsule
  • FDA approves first-time generic Mesalamine Rectal Suspension, USP (enema) for the treatment of mild to moderate ulcerative colitis. The reference listed drug is Rowasa Rectal enema.
  • New and Generic Drug Approvals
    • Aldomet (methyldopa) Tablets, Merck & Co., Labeling Revision
    • AtroPen (atropine) Injection, Meridian Medical, Formulation Revision
    • Cyclosporine Oral Solution, Morton Grove Pharma, Approval
    • Ergotamine Tartrate and caffeine, West-Ward Pharma, Approval
    • Infuvite Adult (multiple vitamins for infusion), Roundtable Healthcare, Labeling Revision
    • Kytril Injection, Hoffman-La Roche, Formulation Revision & Manufacturing Change or Addition
    • Magnevist, (Gadopentetate Dimeglumine) Injection, Berlex, Labeling Revision
    • Mesalamine Rectal Suspension, Clay-Park Labs, Approval
    • Nicotine Polacrilex Gum (2mg Regular), L. Perrigo Co., Approval
    • Nicotine Polacrilex Gum (2mg Orange), L. Perrigo Co., Approval
    • Nicotine Polacrilex Gum (2mg Mint), L. Perrigo Co., Approval
    • Nicotine Polacrilex Gum (4mg Orange), L. Perrigo Co., Approval
    • Nicotine Polacrilex Gum (4mg Mint), L. Perrigo Co., Approval
    • Nicotine Polacrilex Gum (4mg Regular), L. Perrigo Co., Approval
    • Ultravate (halobetasol propionate) Ointment, Bristol Myers Squibb, Labeling Revision
    • Ultravate (halobetasol propionate) Cream, Bristol Myers Squibb, Labeling Revision

September 16, 2004

September 15, 2004

September 14, 2004

  • New and Generic Drug Approvals
    • Avodart (dutasteride) soft-gelatin capsules, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
    • EstroGel (estradiol gel), Solvay Pharmaceuticals, Labeling Revision
    • LEVAQUIN (levofloxacin) Tablets R.W. Johnson Pharmaceutical, Labeling Revision
    • LEVAQUIN (levofloxacin) Injection, R.W. Johnson Pharmaceutical, Labeling Revision
    • Rocephin (ceftriaxone sodium) for injection, Hoffman- La Roche, Labeling Revision
    • Rocephin (ceftriaxone injection), Hoffman- La Roche, Labeling Revision
    • Tequin (gatifloxacin) Tablets, Bristol Myers-Squibb, Labeling Revision
    • Tequin (gatifloxacin in 5% dextrose) Injection, Bristol Myers-Squibb, Labeling Revision
    • Vioxx (rofecoxib) Tablets, Merck & Co., Labeling Revision
    • Vioxx (rofecoxib) Suspension, Merck & Co., Labeling Revision

September 13, 2004

September 10, 2004

  • E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [HTML] or [PDF] or [Word]
  • S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [HTML] or  [PDF] or [Word]
  • New and Generic Drug Approvals
    • Amantadine Hydrochloride Syrup, Silarx Pharmaceuticals, Approval
    • Brimonidine Tartrate Ophthalmic Solution, Ivax Pharma, Approval
    • Ciprofloxacin Tablets, Unique Pharmaceutical, Approval
    • Fluticasone Propionate Cream, KV Pharmaceutical, Approval
    • INVANZ (Ertapenem for Injection), Merck & Co., Labeling Revision
    • M.V.I.-12 (multi-vitamin infusion without vitamin K), Mayne Pharma, New or Modified Indication
  • Public Workshop: Scientific Considerations Related to Developing Follow-On Protein Products, September 14-15, 2004.  Federal Register Notice: [TXT] [PDF] Agenda

September 9, 2004

September 8, 2004

September 7, 2004


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Date revised: October 29, 2004

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