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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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September 15, 2008

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]
    • PDUFA Pilot Project: Proprietary Name Review [PDF]
  • 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

September 5, 2008

September 4, 2008

September 3, 2008

September 2, 2008

  • New and Generic Drug Approvals
    • Dexamethasone Sodium Phosphate Injection, Akorn-Strides, Approval
    • NORVIR (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
    • NORVIR (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
    • Phosphocol P 32 (Chromic Phosphate and P-32) Injection, Mallinckrodt Inc., Labeling Revision
    • Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Formulation Revision
    • Talwin NX (naloxone hydrochloride and pentaz hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision

August 29, 2008

August 28, 2008

  • New and Generic Drug Approvals
    • Estring (estradiol) Extended-Release Vaginal Insert, Pharmacia & Upjohn Co., Labeling Revision
    • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Manufacturing Change or Addition
    • Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision
    • NovoLog Mix 50/50 (insulin aspart protamine and insulin aspart) Injectable Suspension, Novo Nordisk, Inc., Approval
    • Radiogardase (Prussian Blue) (ferric hexacyanoferrate(II)) Capsules, Heyl Chemisch-Pharmazeutische Fabrik GmbH & Co., Package Change

August 27, 2008

August 26, 2008

August 25, 2008

  • FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab).
  • New and Generic Drug Approvals
    • Amicar (aminocaproic acid) Oral solution, Xanodyne Pharmaceuticals, Inc., Labeling Revision
    • Amicar (aminocaproic acid) Tablets, Xanodyne Pharmaceuticals, Inc., Labeling Revision
    • Ceftriaxone (ceftriaxone sodium) Injection, Bedford Laboratories, Approval
    • Losartan Potassium Tablets, Aurobindo Pharma, Ltd., Tentative Approval
    • Metaglip (glipizide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
    • Mucinex (guaifenesin) Extended-Release Tablets, Adams Respiratory Therapeutics, Package Change
    • Pamidronate Disodium Injection, Pliva-Lachema, AS, Approval
    • Qvar 40 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
    • Qvar 80 (beclomethasone dipropionate) Inhalation Aerosol, Teva Global Regulatory Research, LLC, Labeling Revision
    • Rocephin (ceftriaxone sodium) Injection, HLR Technology Corp., Labeling Revision
    • Rocephin Kit (ceftriaxone sodium and lidocaine) Injection, HLR Technology Corp., Labeling Revision
    • Somavert (pegvisomant) Injection, Pharmacia & Upjohn, Labeling Revision
    • Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision
    • Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision
    • Vidaza (azacitidine) Subcutaneous I.V. Injection, Celgene Corp., Efficacy Supplement with Clinical Data to Support

August 22, 2008

August 21, 2008

  • Drug Safety Oversight Board Meeting, July 17, 2008
  • FDA issues an Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). Drug Information
  • Guidance for Industry: Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF] or [HTML]
  • New and Generic Drug Approvals
    • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
    • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
    • Abilify (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
    • Abilify (aripiprazole) Tablets, Otsuka Pharmaceutical Development and Commercialization, Inc., Labeling Revision
    • Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
    • Geodon (ziprasidone mesylate) Intramuscular Injection, Pfizer, Inc., Labeling Revision
    • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Navane (thiothixine) Capsules, Pfizer, Inc., Labeling Revision
    • Risperdal (risperidone) Oral Solution, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Risperdal (risperidone) Orally Disintegrating Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Risperdal (risperidone) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Risperdal Consta (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
    • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
    • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision
    • Symbyax (fluoxetine hydrochloride and olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
    • Zyprexa (olanzapine) Intramuscular Injection, Eli Lilly and Co., Labeling Revision
    • Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Labeling Revision
    • Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Labeling Revision
  • USP Chapter <467> Residual Solvents - Additional Information Adobe Acrobat Symbol

August 20, 2008

August 19, 2008

August 18, 2008

August 15, 2008

August 14, 2008

August 13, 2008

August 12, 2008

  • FDA issues an Information for Healthcare Professionals sheet for Naltrexone. Drug Information.
  • New and Generic Drug Approvals
    • Ak-Fluor (fluorescein sodium) Injection, Akorn, Inc., Approval
    • Cefazolin Injection, Aurobindo Pharma, Ltd., Approval
    • Zovirax (acyclovir) Capsules, GlaxoSmithKline, Labeling Revision
    • Zovirax (acyclovir) Oral Suspension, GlaxoSmithKline, Labeling Revision
    • Zovirax (acyclovir) Tablets, GlaxoSmithKline, Labeling Revision

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Date updated: September 15, 2008

 
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