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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
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October 10, 2008
October 9, 2008
- Drugs Shortages: Cureent Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
- FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
- New and Generic Drug Approvals
- Akten (lidocaine hydrochloride) Ophthalmic Gel, Akorn Inc., Approval
- Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
- Children’s Claritin (loratadine) Chewable Tablets, Schering-Plough HealthCare Products, Inc., Control Supplement
- Fluconazole Tablets, Aurobindo Pharma, Ltd., Approval
- Ketorolac Tromethamine Injection, Sun Pharma Global Inc., Approval
- Lamivudine Tablets, Macleods Pharmaceuticals, Ltd., Tentative Approval
- Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, Depomed, Inc., Labeling Revision
- Zmax (azithromycin) Extended-Release Oral Suspension, Pfizer Inc., Patient Population Altere
October 8, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Avelox (moxifloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Avelox In Sodium Chloride 0.8% In Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Labeling Revision
- Floxin (ofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Levaquin In Dextrose 5% In Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision
October 7, 2008
- FDA issues an updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler). Information
- Guidance for Industry: PDUFA Pilot Project: Proprietary Name Review (finalized) [PDF]
- New and Generic Drug Approvals
- Arsenic Trioxide Injection, Teva Parenteral Medicines, Inc., Tentative Approval
- Cipro (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro In Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer Pharmaceuticals Corp., Labeling Revision
- Cipro XR (ciprofloxacin and ciprofloxacin hydrochloride) Extended-Release Tablets, Bayer Pharmaceuticals Corp., Labeling Revision
- Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change
- Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
- Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Primidone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision
- Warning Letter: YAZ (drospirenone and ethinyl estradiol) Tablets
October 6, 2008
- Emergency Use Authorization (EUA) for the Pre-Event Provision and Potential Use of Doxycycline Hyclate Tablet Emergency Kits for Inhalational Anthrax
- Inactive Ingredient Database (updated)
- New and Generic Drug Approvals
- Bromocriptine Mesylate Tablets, Paddock Laboratories, Inc., Approval
- Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Galantamine Hydrobromide Extended-release Capsules , Barr Laboratories, Inc., Approval
- Hylenex[rDNA origin] (hyaluronidase [rDNA origin]) Injection, Halozyme Therapeutics Inc., Labeling Revision
- Nitrolingual (nitroglycerin) Spray, Sciele Pharma, Inc., Package Change
October 3, 2008
October 2, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: Comprehensive List of Guidance Documents
- Guidance for Industry: New/Revised/Withdrawn List for 2008
- Investigational Human Drugs: Clinical Investigator Inspection List (updated)
- New and Generic Drug Approvals
- Curosurf (poractant alpha) Intratracheal Suspension, Dey, L.P., Labeling Revision
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- EpiPen and Epi E Z Pen Jr (epinephrine) Intramuscular Injection, Meridian Medical Technologies Inc., Labeling Revision
- Exubera (insulin human [rDNA origin]) Inhalation Powder, Labeling Revision
- Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Patient Population Altered
- Videx Ec (didanosine) Delayed Release Capsules, Bristol-Myers Squibb Co., Patient Population Altered
- Warning Letter: Mirapex (pramipexole dihydrochloride)
October 1, 2008
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial) (updated)
- New and Generic Drug Approvals
- Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval
- Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Promethazine Hydrochloride Injection, Wockhardt USA, Inc., Approval
- Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision
- Tramadol Hydrochloride and Acetaminophen Tablets, Alphapharm Party, Ltd., Approval
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Paragraph IV Patent Certifications (updated)
September 30, 2008
- New and Generic Drug Approvals
- Adagen (pegademase bovine) Injection, Enzon Pharmaceuticals, Inc., Labeling Revision
- Alfuzosin Hydrochloride Extended-Release Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
- Alprazolam Tablets, Vintage Pharmaceuticals, LLC, Approval
- Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
- Exubera (insulin [rDNA origin]) Inhalation Powder, Pfizer Inc., Labeling Revision
- Hydroxyzine Hydrochloride Tablets, Amneal Pharmaceuticals, Approval
- Moexipril Hydrochloride and Hydrochlorothiazide Tablets, Paddock Laboratories, Inc., Approval
- Tamiflu (oseltamivir phosphate) Capsules, Hoffmann-La Roche, Inc., Labeling Revision
- Vaseretic (enalapril maleate and hydrochlorothiazide) Tablets, Biovail Laboratories International SRL, Labeling Revision
- Vasotec (enalapril maleate) Tablets, Biovail Laboratories International SRL, Labeling Revision
September 29, 2008
- Drug Development and Drug Interactions: Meetings: FDA Critical Path Transporter Workshop - (updated)
- On September 26th, FDA approves Alimta (pemetrexed) injection for use in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Prescribing Information
- Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration - (updated)
September 26, 2008
- Guidance for Industry: Individual Product Bioequivalence Recommendations 19 Newly added Bioequivalents.
- Drugs Shortages: Drugs to be Discontinued: SecreFlo (porcine secretin for injection, 16 mcg/vial)
- Drugs Shortages: Resolved Drugs Shortages: Zanosar (Streptozocin) 1gm/vial Injection
- FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. MedWatch Safety Information
- New and Generic Drug Approvals
- Betamethasone Dipropionate Topical Cream, Glenmark Generics, Approval
- Didanosine Delayed-Release Capsules, Aurobindo Pharma, Approval
- Heparin Sodium Injection, APP Pharmaceuticals, LLC, Labeling Revision
- Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Labeling Revision
- Nabumetone Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Noroxin (norfloxacin) Tablets, Merck & Co. Inc., Labeling Revision
- Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision
- Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
- Office of Generic Drugs: List of Authorized Generic Drugs (updated)
- Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers (podcast)
- Warning and Untitled Letters
- Adderall XR Capsules (Warning Letter)
- Concerta (methylphenidate HCl)
- Diovan (valsartan) Tablets
- Focalin XR (dexmethylphenidate)
- Methylin (methylphenidate HCl)
- Strattera (atomoxetine HCl) (Warning Letter)
September 25, 2008
- FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers (updated)
- Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]
- International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
- New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Torrent Pharmaceuticals, Ltd., Approval
- Carboplatin I.V. Injection, Sun Pharmaceutical Industries, Ltd., Approval
- Nasacort AQ (triamcinolone acetonide) Nasal Spray, Sanofi-Aventis US, LLC, Patient Population Altered
- RETROVIR (zidovudine) Capsules, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Syrup, GlaxoSmithKline, New Dosage Regimen
- RETROVIR (zidovudine) Tablets, GlaxoSmithKline, New Dosage Regimen
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., New Dosage Regimen
- Technetium Tc 99m Sestamibi (technettium tc-99m sestamibi kit) Injection, Mallinckrodt Inc., Approval
- Ventavis (iloprost) Inhalation Solution, Actelion, Ltd., Labeling Revision
September 24, 2008
September 23, 2008
September 22, 2008
- FDA orders companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Questions and Answers
- FDA orders companies to stop marketing unapproved ophthalmic balanced salt solutions (BSS). Questions and Answers
September 19, 2008
- FDA approves iobenguane I 123 injection (AdreView, GE Healthcare), a diagnostic radiopharmaceutical, for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests. Prescribing Information.
- New and Generic Drug Approvals
- Carbidopa and Levodopa Orally Disintegrating Tablets, Mylan Pharmaceuticals, Inc., Approval
- Celexa (citalopram hydrobromide) Oral Solution, Forest Laboratories, Inc., Labeling Revision
- Celexa (citalopram hydrobromide) Tablets, Forest Laboratories, Inc., Labeling Revision
- Epirubicin Hydrochloride Injection, Activis Totowa, LLC, Approval
- Lexapro (escitalopram oxalate) Oral Solution, Forest Laboratories, Inc., Labeling Revision
- Lexapro (escitalopram oxalate) Tablets, Forest Laboratories, Inc., Labeling Revision
- Ziprasidone Hydrochloride Capsules, Sandoz, Inc., Tentative Approval
September 18, 2008
- Covidien and Mallinckrodt Inc. inform healthcare professionals of important new safety information in prescribing Phosphocol P 32. MedWatch Safety Information
- Drug Shortages: Current Drug Shortages; Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
- Drugs Shortages: Drugs to be Discontinued: Mitozytrex (Mitomycin for Injection)
- FDA releases its fourth issue of the FDA Drug Safety Newsletter
- International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration
- List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. (updated)
- New and Generic Drug Approvals
- Amiodarone Hydrochloride Tablets, Zydus Pharmaceuticals USA Inc., Approval
- Glucovance (glyburide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Keflex (cephalexin) Capsules, MiddleBrook Pharmaceuticals, Labeling Revision
- Proair HFA (albuterol sulfate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Patient Population Altered
- Protriptyline Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
September 17, 2008
- Drugs@FDA Downloadable Data Files (updated)
- Guidance for Industry: S1C(R2) Guidance on
Dose Selection for Carcinogenicity Studies of Pharmaceuticals [PDF] or [HTML]
- New and Generic Drug Approvals
- Galantamine Hydrobromide Extended-Release Capsules, Barr Laboratories, Inc., Approval
- Lybrel (levonorgestrel and ethinyl estradiol) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
- Risperidone Tablets, Apotex Corp., Approval
- Risperidone Tablets, Mylan Pharmaceuticals, Inc., Approval
September 16, 2008
- FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India. Drug Information.
- Meetings of the Nonprescription Drugs Advisory Committee (NDAC) (updated)
- New and Generic Drug Approvals
- Hydralazine Hydrochloride Tablets, Hetero Drugs, Ltd., Approval
- Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Approval
- Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Matrix Laboratories, Ltd., Tentative Approval
- Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
- Sancuso (granisetron) Transdermal System, Strakan International, Ltd., Approval
- Tarceva (erlotinib hydrochloride) Tablets, OSI Pharmaceuticals, Inc., Labeling Revision
- Rulemaking History for OTC Sunscreen Drug Products: Time and Extent Applications (updated)
September 15, 2008
- New and Generic Drug Approvals
- Alendronate Sodium Tablets, Sun Pharmaceutical Industries, Ltd., Approval
- Detrol (tolterodine tartrate) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
- Detrol LA (tolterodine tartrate) Extended-Release Capsules, Pfizer Global Pharmaceuticals, Labeling Revision
- Galantamine Hydrobromide Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- NeoProfen (ibuprofen lysine) Intravenous Injection, Ovation Pharmaceuticals, Inc., Labeling Revision
- Potassium Chloride 0.149% in Sodium Chloride 0.45% in Plastic Container (potassium chloride and sodium chloride) Injection, Hospira Inc., Approval
- Remodulin (treprostinil sodium) Subcutaneous I.V. Injection, United Therapeutics Corp., Labeling Revision
- Stromectol (ivermectin) Tablets, Merck & Co., Inc., Labeling Revision
September 12, 2008
September 11, 2008
September 9, 2008
- Cyber Letters for Years: 2005, 2006, 2007 (updated)
- Guidance for Industry: Concept Papers
- Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF] or [HTML]
- PDUFA Pilot Project: Proprietary Name Review [PDF] or [HTML]
- New and Generic Drug Approvals
- Monistat 3 (miconazole nitrate) Vaginal Cream, Johnson and Johnson Healthcare Products, Manufacturing Change or Addition
- Photofrin (porfimer sodium) Injection, Axcan Pharma US, Inc., Efficacy Supplement with Clinical Data to Support
September 8, 2008
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Date updated:
October 10, 2008
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