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

• 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

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
• CDER Organization Charts [HTML] [PDF] (updated)
• Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
• Genentech informs healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML). MedWatch Safety Information

September 11, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

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

• Warning Letter: Bystolic (nebivolol) Tablets

September 5, 2008

• Adverse Event Reporting System (AERS) (updated)
• FDA posts quarterly report of potential safety issues. FDA News
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Labeling Revision
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008

September 4, 2008

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Dissolution Methods Database (updated)
• FDA announces that manufacturers of TNF-blocker drugs (Cimzia, Enbrel, Humira, and Remicade) must highlight the risk of fungal and serious opportunistic infections. FDA News
• National Drug Code Directory (updated)
• New and Generic Drug Approvals
  • Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., Tentative Approval
  • Aceon (perindopril erbumine)Tablets, Solvay Pharmaceuticals, Inc., Labeling Revision
  • Levemir (insulin detemir [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • NovoLog Mix 70/30 (insulin aspart protamine [rDNA origin] and insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • Stavudine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval
• Office of Generic Drugs: News and Announcements (updated)

September 3, 2008

• Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF] or [HTML]
• New and Generic Drug Approvals
  • Clotrimazole Topical Cream, Nycomed US Inc., Approval
  • Ketotifen Fumarate Ophthalmic Solution, Alcon Inc., Approval
  • Ramipril Capsules, Zydus Pharmaceuticals USA Inc., Approval
  • Ranitidine (ranitidine hydrochloride) Syrup, Amneal Pharmaceuticals, Approval
  • Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Patient Population Altered
• Office of Generic Drugs: August First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)
• What You Should Know about Prescription Drug Advertisements

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

• Cyber Letters (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Natural Disaster Response (updated)
• New and Generic Drug Approvals
  • Galantamine Hydrobromide Tablets, Alphapharm Party, Ltd., Approval
  • Galantamine Hydrobromide Tablets, Barr Laboratories, Inc., Approval
  • Glucophage (metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Glucophage XR (metformin hydrochloride) Extended-Release Tablets, Bristol-Myers Squibb Co., Labeling Revision
  • Sandostatin (octreotide acetate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Zemuron (rocuronium bromide) Injection, Organon USA, Inc., Patient Population Altered

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

• Division of Antiviral Products (DAVP) Getting Started with the Pre-IND Process (contact information updated)
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Integrated Summary of Effectiveness [PDF] or [HTML]
• New and Generic Drug Approvals
  • Omnitrope (somatropin [rDNA origin] Injection, Sandoz, Inc., Formulation Revision
  • Salonpas Patch (methyl salicylate and menthol), Hisamitsu Pharmaceutical Co., Inc., Package Change
  • Trandolapril Tablets, Dr. Reddy's Laboratories, Ltd., Approval
• Office of Antimicrobial Products (OAP) Pre-IND Consultation Program: Pre-IND Consultation Contact List (updated)

August 26, 2008

• Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
• New and Generic Drug Approvals
  • Aloxi (palonosetron hydrochloride) Capsules, Helsinn Healthcare, SA, Approval
  • Monistat 7 (miconazole nitrate) Vaginal Cream, Johnson & Johnson Healthcare Products, Manufacturing Change or Addition
  • Precose (acarbose) Tablets, Bayer HealthCare Pharmaceuticals, Labeling Revision

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

• Guidance for Industry: Bioequivalence Guidances: New additions for August 2008.
• New and Generic Drug Approvals
  • Bupropion Hydrochloride Extended-Release Tablets, Actavis South Atlantic, LLC, Approval
  • Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Dexamethasone Tablets, ECR Pharmaceuticals, Approval
  • FazaClo ODT (clozapine) Orally Disintegrating Tablets, Azur Pharmaceuticals International, Ltd., Labeling Revision
  • Hydrochlorothiazide Tablets, Unichem Laboratories Ltd., Approval
  • OptiMARK (gadoversetamide) Injection, Mallinckrodt, Inc., Labeling Revision
  • REYETAZ (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Labeling Revision
  • Sumatriptan Succinate Injection, Wockhardt Ltd., Tentative Approval 
  • Xenazine (tetrabenazine) Tablets, Prestwick Pharmaceuticals, Inc., Approval 
• Public Hearing for Over-the-Counter Cough and Cold Medications, October 2, 2008, Beltsville, Maryland: Meeting information and registration

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

August 20, 2008

• PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, September 10-12, 2008, Washington, D.C. Meeting information and registration
• The Prescription Drug User Fee Act (PDUFA) News: The FY 2009 Product and Establishment Fee Invoices were mailed Friday, August 15, 2008. Full payment of the invoice is due by October 1, 2008. If you do not receive your invoice by August 25, 2008, please contact Michael Jones or Beverly Friedman at 301-796-3602.
• Generic Drug Petition Tracking: Suitability Tracking Reports (updated)

August 19, 2008

• Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
• New and Generic Drug Approvals
  • Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
  • Children's Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
  • Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Formulation Revision
  • Children's Zyrtec Hives Relief (cetirizine hydrochloride) Syrup, McNeil-PPC, Inc., Labeling Revision
  • Haldol (haloperidol decanoate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Haldol (haloperidol lactate) Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Moban (molindone hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision
  • Megace ES (megestrol acetate) Oral Suspension, Par Pharmaceutical, Inc., Labeling Revision
  • Thyrogen (thyrotropin alfa) Injection, Genzyme Corp., Labeling Revision

August 18, 2008

• FDA updates the Information for Healthcare Professionals sheet for Byetta (exenatide).
• Paragraph IV Patent Certifications (updated)

August 15, 2008

• Drug Approval Reports
  • NDA and BLA Approvals (updated)
  • New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplements Approved (CY 2008) (updated)
  • NME Drug and New Biologic Approvals (updated)
  • Priority NDA and BLA Approvals (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

• Medical Center Pharmacy v. Mukasey

August 13, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Docetaxel Injection, Hospira, Inc., Tentative Approval
  • Fluorouracil Injection, Ebewe Pharma, Approval
  • Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca LP, Manufacturing Change or Addition
  • Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., New or Modified Indication
• Watson Pharmaceuticals, Inc. issues a voluntary recall of one lot of 75mcg/hr Fentanyl Transdermal System patches. MedWatch Safety Information

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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