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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
September 5, 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
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
- 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
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
August 15, 2008
August 14, 2008
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
August 11, 2008
- Cyber Letters for year 2005 and 2006 (updated)
- Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
- New and Generic Drug Approvals
- Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
- Cefepime Injection, Baxter Healthcare Corp., Approval
- Cialis (tadalafil) Tablets, Eli Lilly and Co., Labeling Revision
- Corzide (bendroflumethiazide and nadolol) Tablets, King Pharmaceuticals, Labeling Revision
- Femara (letrozole) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Kerlone (betaxolol hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
- Ramipril Capsules, Cipla Ltd, Approval
- Talacen (acetaminophen and pentazocine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
August 8, 2008
- CDER Manual of Policies and Procedures (MaPP) 4641.3R Outside Activities
- FDA issues an Information for Healthcare Professionals sheet for Amiodarone and Simvastatin. Drug Information.
- Genomics at FDA (updated)
- New and Generic Drug Approvals
- Alendronate Sodium Tablets, Apotex, Inc., Approval
- Alendronate Sodium Tablets, Aurobindo Pharma, Ltd., Approval
- Alendronate Sodium Tablets, Barr Laboratories, Inc., Labeling
- Alendronate Sodium Tablets, Cobalt Laboratories, Inc., Approval
- Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Alendronate Sodium Tablets, Dr. Reddy's Laboratories, Ltd., Approval
- Alendronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Approval
- Alendronate Sodium Tablets, Watson Laboratories, Inc., Approval
- Aleve Cold and Sinus (naproxen sodium and pseudoephedrine hydrochloride) Extended-Release Tablets, Bayer Healthcare, LLC, Labeling Revision
- Cleviprex (clevidipine butyrate) Injectable Emulsion, The Medicines Co., Approval
- Eplerenone Tablets, Sandoz, Inc., Approval
- Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Efficacy Supplement with Clinical Data to Support
- Symlin (pramlintide acetate) Subcutaneous Injection, Amylin Pharmaceuticals, Inc. Labeling Revision
- Viagra (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision
- Pediatric Research Equity Act (PREA) Labeling Changes (updated)
August 7, 2008
- BPCA/Pediatric Exclusivity Statistics:
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Adenosine Injection, Teva Parenteral Medicines, Approval
- Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Control Supplement
- Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Formulation Revision
- Ceftriaxone (ceftriaxone sodium) Intramuscular I.V. Injection, Aurobindo Pharma Ltd., Approval
- Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indicatiion
- Divalproex Sodium Delayed-Release Tablets, Wockhardt USA, Inc., Approval
- Dorzolamide Hydrochloride Ophthalmic Solution, Apotex Corp., Tentative Approval
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Apotex Corp., Tentative Approval
- Lupron Depot-Ped (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
- Ranitidine (ranitidine hydrochloride) Tablets, Wockhardt USA, Inc., Approval
August 6, 2008
August 5, 2008
August 4, 2008
- Guidance for Industry: E2F Development Safety Update Report [PDF] or [HTML]
- Guidance for Industry:
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions;
- Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [PDF] or [HTML]
- Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF] or [HTML]
- Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF]
- Annex 5: Disintegration Test General Chapter [PDF] or [HTML]
- Guidance for Industry: Labeling OTC Skin Protectant Drug Products [PDF] or [HTML]
- Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes [PDF] or [HTML]
- Office of Generic Drugs: July First-Time Generic Drug Approvals
August 1, 2008
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Date updated:
September 5, 2008
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