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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
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View New Items by Category
May 11, 2009
May 8, 2009
- CDER Organization Charts [HTML] [PDF] (updated)
- Drug Shortages: Current Drug Shortage: Mitomycin for injection (updated)
- New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Alkem Laboratories Ltd., Approval
- Ancoban (flucytosine) Capsules, Valeant Pharmaceuticals International, Labeling Revision
- Cancidas (caspofungin acetate) Injection, Merck Research Laboratories, Labeling Revision
- CeeNu (lomustine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
- Children's Motrin Cold (ibuprofen and pseudoephedrine hydrochloride) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision
- Children's Motrin (ibuprofen) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision
- Dilaudid-HP (hydromorphone hydrochloride) Injection, Purdue Pharma L.P., New Dosage Regimen
- Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Approval
- Granisetron Hydrochloride Injection, Sandoz Canada Inc., Approval
- Levetiracetam Tablets, Zydus Pharmaceuticals USA Inc., Approval
- Mivacurium Chloride Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
- Orap (pimozide) Tablets, Teva Pharmaceuticals, USA, Labeling Revision
- Risperidone Orally Disintegrating Tablets, Zydus Pharmaceuticals USA Inc., Approval
- Risperidone Orally Disintegrating Tablets, Kali Laboratories, Inc., Approval
- Stromectol (ivermectin) Tablets, Merck & Co., Inc., Labeling Revision
- Tenofovir Disoproxil Fumarate Tablets, Cipla Ltd., Tentative Approval
- Treanda (bendamustine hydrochloride) I.V. Powder, Cephalon, Inc., Control Supplement
- Tyzeka (telbivudine) Oral Solution, Novartis Pharmaceuticals Corp., Approval
- Vancomycin Hydrochloride Injection, Hospira Inc., Approval
- Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
- The Dear Colleague Letter, in anticipation of FY 2010 Invoices, was mailed Tuesday, May 5, 2009
May 7, 2009
- Drug Shortages: Current Drug Shortage: Metoprolol succinate extended release tablets (updated)
- Drug Shortages: Current Drug Shortage: Mitomycin for injection (updated)
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry:
- New and Generic Drug Approvals
- Arimidex (anastrozole) Tablets, AstraZeneca, Labeling Revision
- Axert (almotriptan malate) Tablets, Johnson & Johnson Pharmaceutical Research & Development, Labeling Revision
- Azelastine Hydrochloride Nasal Spray, Apotex Inc., Approval
- Butorphanol Tartrate Injection, Hikma Famaceutica, Approval
- CETRAXAL (ciprofloxacin) Otic Solution, Laboratorios SALVAT, S.A., Approval
- Children’s Motrin (ibuprofen) Oral Suspension, McNeil Consumer Healthcare, Labeling Revision
May 6, 2009
May 5, 2009
- FDA issues an Update about Suicidal Behavior and Ideation and Antiepileptic Drugs
- New and Generic Drug Approvals
- Adenosine Injection, Wockhardt, Ltd., Tentative Approval
- Adenosine Injection, Luitpold Pharmaceuticals, Inc., Approval
- Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
- Junior Strength Motrin (ibuprofen) Chewable Tablets, McNeil Consumer Healthcare, Labeling Revision
- Levaquin (levofloxacin) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Levaquin (levofloxacin) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Levaquin (levofloxacin) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Lorazepam Oral Concentrate, Paddock Laboratories, Inc., Approval
- Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision
- Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets, BioMarin Pharmaceutical, Inc., Manufacturing Change or Addition
- Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed, Inc., Labeling Revision
- Technetium Tc 99m Sestamibi Injection, Cardinal Health 414, LLC, Approval
May 4, 2009
May 1, 2009
- Drugs@FDA Downloadable Data Files (updated)
- FDA approves pancrelipase (Creon Delayed-Release Capsules) for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions. Drug information
- New and Generic Drug Approvals
- Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation Labeling Revision
- Avelox (moxifloxacin hydrochloride in NaCl injection) I.V. Injection, Bayer Pharmaceuticals Corporation Labeling Revision
- Cetirizine Hydrochloride Syrup, Dr. Reddy's Laboratories, Inc., Approval
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
- Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corporation, Labeling Revision
- Cipro in Dextrose in Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corporation, Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corporation, Labeling Revision
- Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corporation, Labeling Revision
- Creon (pancrelipase) Delayed-Release Capsules, Solvay Pharmaceuticals, Approval
- Donepezil Hydrochloride Tablets, Apotex, Inc., Tentative Approval
- Duraclon (clonidine hydrochloride) Injection, Xanodyne Pharmaceuticals, Inc., Labeling Revision
- Equetro (carbamazepine) Extended-Release Capsules, Validus Pharmaceuticals, Labeling Revision
- Ezetimibe Tablets, Glenmark Generics Limited, Tentative Approval
- Felbatol (felbamate) Tablets and Oral Suspension, Meda Pharmaceuticals, Inc., Labeling Revision
- Fexofenadine Hydrochloride Tablets, Sandoz, Inc., Tentative Approval
- Gabitril (tiagabine hydrochloride) Tablets, Cephalon, Inc., Labeling Revision
- Glycet (miglitol) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
- Kayexalate (sodium polystyrene sulfonate) Oral or Rectal Powder, Sanofi-Aventis U.S., LLC, Labeling Revision
- Keppra (levetiracetam) Tablets, UCB, Inc., Labeling Revision
- Keppra (levetiracetam) Oral Solution, UCB, Inc., Labeling Revision
- Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Labeling Revision
- Levofloxacin Ophthalmic Solution, Apotex Inc., Tentative Approval
- Linezolid Tablets, Glenmark Generics Limited, Tentative Approval
- Motrin IB (ibuprofen) Tablets, McNeil Consumer Healthcare, Labeling Revision
- Motrin Junior Strength Tablets, McNeil Consumer Healthcare, Labeling Revision
- Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Labeling Revision
- Stavzor (valproic acid) Delayed-Release Capsules, Banner Pharmacaps, Inc., Labeling Revision
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
- Topamax (topiramate) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Topamax Sprinkle (topiramate) Capsules, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
- Velcade (bortezomib) Intravenous Injection, Millennium Pharmaceuticals, Inc., Manufacturing Change or Addition
- Zonegran (zonisamide) Capsules, Dainippon Pharmaceutical USA Corporation, Labeling Revision
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
April 30, 2009
- Drug Shortages: Current Drug Shortage: Methotrexate injection
- FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
- Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products PDF
- New and Generic Drug Approvals
- Depakene (valproic acid) Capsules, Abbott Laboratories, Labeling Revision
- Depakene (valproic acid) Syrup, Abbott Laboratories, Labeling Revision
- Depakote (divalproex sodium) Delayed-Release Capsules, Abbott Laboratories, Labeling Revision
- Depakote (divalproex sodium) Delayed-Release Tablets, Abbott Laboratories, Labeling Revision
- Depakote ER (divalproex sodium) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
- Klonopin (clonazepam) Tablets, Hoffmann-La Roche Inc., Labeling Revision
- Klonopin Rapidly Disintegrating (clonazepam) Orally Disintegrating Tablet, Hoffmann-La Roche Inc., Labeling Revision
- Lamictal (lamotrigine) Chewable Tablets, GlaxoSmithKline, Labeling Revision
- Lamictal (lamotrigine) Tablets, GlaxoSmithKline, Labeling Revision
- Lyrica (pregabalin) Capsules, Pfizer, Inc., Labeling Revision
- Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-LaRoche Inc., LabelingRevision
- Tamiflu (oseltamivir phosphate) Oral Suspension, Hoffmann-LaRoche Inc., LabelingRevision
- Tegretol (carbamazepine) Chewable Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Tegretol (carbamazepine) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Tegretol (carbamazepine) Oral Suspension, Novartis Pharmaceuticals Corp., Labeling Revision
- Tegretol (carbamazepine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Tridione (trimethadione) Tablets, Abbott Laboratories, Labeling Revision
- Trileptal (oxcarbazepine) Oral Suspension, Novartis Pharmaceuticals Corp., Labeling Revision
- Trileptal (oxcarbazepine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
April 29, 2009
April 28, 2009
- Manual of Policies and Procedures (MaPP) 5100.4 Scientific Interest Groups: Criteria and Policies
- Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution (updated)
- New and Generic Drug Approvals
- BSS (calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride and sodium citrate) Irrigation Solution, Alcon Laboratories, Inc., Package Change
- Carbatrol (carbamazepine) Extended-Release Capsules, Shire Development, Inc., Labeling Revision
- Celontin (methsuximide) Capsules, Pfizer, Inc., Labeling Revision
- Dilantin-125 (phenytoin) Oral Suspension, Pfizer, Inc., Labeling Revision
- Neurontin (gabapentin) Capsules, Pfizer, Inc., Labeling Revision
- Neurontin (gabapentin) Tablets, Pfizer, Inc., Labeling Revision
- Neurontin (gabapentin) Oral Solution, Pfizer, Inc., Labeling Revision
- Peganone (ethotoin) Tablets, Ovation Pharmaceuticals, Inc., Labeling Revision
- Pristiq (desvenlafaxine succinate) Extended-Release Tablets, Wyeth Pharmaceuticals Inc., Control Supplement
- Tranxene (clorazepate dipotassium) Capsules, Ovation Pharmaceuticals, Inc., Labeling Revision
- Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
- The U.S. Food and Drug Administration and the U.S. Substance Abuse and Mental Health Services Administration launched an initiative to help ensure the safe use of methadone. For more information on the campaign, or to download free copies of the educational materials, please visit www.dpt.samhsa.gov/methadonesafety
April 27, 2009
- Risk Evaluation and Mitigation Strategies (REMS) and Opioid Analgesics Webinar
- Drug Shortages: Resolved Drug Shortage: Leucovorin Calcium Solution for Injection
- Drug Shortages: Resolved Drug Shortage: Levoleucovorin (Fusilev) 50 mg single use vials
- New and Generic Drug Approvals
- Alendronate Sodium Tablets, Sandoz, Inc., Approval
- Asacol HD (mesalamine) Delayed-Release Tablets, Procter & Gamble Pharmaceuticals, Inc., Labeling Revision
- Bethanechol Chloride Tablets, Sun Pharmaceutical Industries, Inc., Approval
- Claritin-D (loratadine and pseudoephedrine sulfate) Extended-Release Tablets, Schering-Plough Healthcare Products, Formulation Revision
- Cordarone (amiodarone hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Mycophenolate Mofetil Capsules, Apotex Inc., Approval
- Mycophenolate Mofetil Tablets, Apotex Inc., Approval
- Sarafem (fluoxetine hydrochloride) Tablets, Warner Chilcott Company, Inc., Labeling Revision
- SPORANOX (itraconazole) Injection, Johnson & Johnson Pharmaceutical Research and Development, Labeling Revision
- Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
- Topamax (topiramate) Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
- Treanda (bendamustine hydrochloride) I.V. Powder, Cephalon, Inc., Labeling Revision
April 24, 2009
April 23, 2009
- Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated)
- Drugs@FDA Downloadable Data Files (updated)
- FDA updates action on Plan B (levonorgestrel) tablets. FDA Statement
- New and Generic Drug Approvals
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Efficacy Supplement with Clinical Data to Support
- Lovaza (omega-3-acid ethyl esters) Capsules, GlaxoSmithKline, Labeling Revision
- Omeprazole Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Approval
- Prismasol (calcium chloride, dextrose, lactic acid, magnesium chloride, potassium chloride, sodium bicarbonate and sodium chloride) Injection, Gambro, Package Change
- Topiramate Capsules, Teva Pharmaceuticals USA, Approval
April 22, 2009
April 21, 2009
- New and Generic Drug Approvals
- Aleve-D Sinus & Cold (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer HealthCare Consumer Care, Labeling Revision
- Doxycycline Tablets, Mutual Pharmaceutical Co., Inc., Approval
- Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision
- Savella (milnacipran hydrochloride) Tablets, Cypress Bioscience, Inc., Control Supplement
April 20, 2009
- Drug Shortages: Resolved Drug Shortage: Acyclovir Injection
- Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [PDF]
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Aleve (naproxen sodium) Tablets, Bayer HealthCare LLC, Labeling Revision
- Topiramate Capsules, Barr Laboratories, Inc., Approval
- Topiramate Capsules, Zydus Pharmaceuticals USA Inc., Tentative Approval
- Topiramate Capsules, Sandoz Inc., Tentative Approval
- Topiramate Capsules, Cobalt Laboratories Inc., Approval
- Paragraph IV Patent Certifications (updated)
- Quality Risk Management – Implementation Strategies; U.S. FDA/CDER and University of Rhode Island College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency Bethesda, Bethesda, Maryland. Meeting Information.
April 17, 2009
- Inactive Ingredient Search for Approved Drug Products (updated)
- Investigational Human Drugs: Clinical Investigator Inspection List (updated)
- New and Generic Drug Approvals
- Dorzolamide Hydrochloride Ophthalmic Solution, Alcon, Inc., Approval
- Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
- Lexiva (fosamprenavir calcium) Oral Suspension, GlaxoSmithKline, Labeling Revision
- Mitoxantrone Hydrochloride Injection, GeneraMedix, Inc., Approval
- Ondansetron Hydrochloride and Dextrose in Plastic Container Injection, Bedford Laboratories, Approval
- Suprane (desflurane) Inhalation Liquid, Baxter Healthcare Corp., Labeling Revision
- Zoledronic Acid I.V. Injection, Apotex, Inc., Tentative Approval
April 16, 2009
- Guidance for Industry: Submission of Summary Bioequivalence Data for ANDAs [PDF]
- New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Glenmark Generics, Ltd., Approval
- Benzyl Alcohol (benzyl alcohol) Lotion, Sciele Pharma, Inc., Approval
- Coartem (artemether and lumefantrine) Tablets, Novartis Pharmaceuticals Corp., Approval
- Depo-Medrol (methylprednisolone acetate) Injection, Pfizer Global Research and Development, Labeling Revision
- Detrol (tolterodine tartrate) Tablets, Pfizer Global Research and Development, Labeling Revision
- Extraneal (icodextrin) Peritoneal Solution, Baxter Healthcare Corp., Labeling Revision
- Mavik (trandolapril) Tablets, Abbott Laboratories (GPRA), Labeling Revision
- Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate Chewable Tablets, Barr Laboratories, Inc., Approval
- Oxycodone Hydrochloride Tablets, Sun Pharmaceutical Industries, Inc., Approval
- Ranitidine Syrup, Dr. Reddy's Laboratories, Ltd., Tentative Approval
- Requip XL (ropinirole hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Formulation Revision
- Office of Generic Drugs: Determination of Topiramate Sprinkle Capsules Exclusivity
April 15, 2009
April 14, 2009
April 9, 2009
- FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml
- Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announces that it has begun a voluntary, phased withdrawal of the product from the U.S. market.
- Bioresearch Monitoring Information System (BMIS) (updated)
- Dissolution Methods Database (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortage: Acyclovir Injection (updated)
- National Drug Code Directory (updated)
- New and Generic Drug Approvals
- CIPRO (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- CIPRO (ciprofloxacin hydrochloride) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
- Claritin (loratadine) Capsules, Schering-Plough, Labeling Revision
- Fomepizole Injection, GeneraMedix, Inc., Approval
- Ibandronate Sodium Injection, Teva Parenteral Medicines, Inc., Tentative Approval
- KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- LUNESTA (eszopiclone) Tablets, Sepracor, Inc., Package Change
- Minipress (prazosin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
- Mucinex DM (guaifenesin and dextromethorphan) Extended-Release Tablets, Reckitt Benckiser, Package Change
April 8, 2009
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Date updated:
May 11, 2009
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