• Drug Shortages:
  • Fentanyl transdermal patch (updated)
  • MVI Adult Injectable (updated)
• Electronic Common Technical Document (eCTD) (updated)
• New and Generic Drug Approvals
  • Advil Cold & Sinus (ibuprofen and pseudoephedrine HCl) Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • Avodart (dutasteride) Soft Gelatin Capsule, GlaxoSmithKline, New or Modified Indication
  • Cetirizine Hydrochloride Syrup, Ranbaxy Inc., Approval
  • Junior Strength Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • Lamivudine/Stavudine Tablets, Cipla Ltd., Tentative Approval
  • Ramipril Capsules, Actavis Mid Atlantic, LLC, Approval
  • Ramipril Capsules, Sandoz Inc., Approval
  • Ramipril Capsules, Roxane Laboratories, Inc., Approval
  • Ramipril Capsules, Invagen Pharmaceuticals, Inc., Approval
  • Ramipril Capsules, Teva Pharmaceuticals USA, Approval
  • Ramipril Capsules, Dr. Reddy's Laboratories, Ltd., Approval
• Office of Generic Drugs: May First-Time Generic Drug Approvals
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

June 19, 2008

• Manual of Policies and Procedures (MaPP) 4151.6 "Drug Safety Newsletter"
• New and Generic Drug Approvals
  • Agrylin (anagrelide hydrochloride) Capsules, Shire Development, Inc., Labeling Revision
  • Buprenorphine Hydrochloride Tablets, Roxane Laboratories, Inc., Tentative Approval
  • Byetta (exenatide synthetic) Injection, Amylin Pharmaceuticals, Inc., Labeling Revision
  • Cetirizine Hydrochloride Syrup, Apotex Corp., Approval
  • Cetirizine Hydrochloride Syrup, Perrigo Israel Pharmaceuticals, Ltd.., Approval
  • Claritin (loratadine) Capsules, Schering-Plough HealthCare Products, Approval
  • Hydromorphone Hydrochloride Injection, Hospira, Inc., Approval
  • Metoprolol Tartrate Tablets, Ohm Laboratories, Inc., Approval
  • Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Package Change
  • Ribavirin Tablets, Three Rivers Pharmaceuticals, LLC, Packager Addition
  • Synercid (quinupristin and dalfopristin) I.V., King Pharmaceuticals, Inc., Labeling Revision
  • Trandolapril Tablets, Glenmark Generics Inc., USA, Approval
  • Trivaris (triamcinolone acetonide) Injectable Suspension, Allergan, Inc., Approval
• Office of Compliance
  • Contact Information (updated)
  • Immediate Office Staff (updated)

June 18, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Approval
  • Mysoline (primidone) Tablets, Valeant Pharmaceuticals International, Manufacturing Change or Addition
  • Pulmicort Flexhaler (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
  • Requip XL (ropinirole) Extended-Release Tablets, GlaxoSmithKline, Approval
  • Sodium Iodide I-123 Capsules, Syncor Pharmaceuticals, Inc., Labeling Revision
  • Venlafaxine Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Venlafaxine Hydrochloride Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Venlafaxine Hydrochloride Tablets, Pliva Hrvatska, Approval
  • Venlafaxine Hydrochloride Tablets, Sandoz, Inc., Approval
  • Venlafaxine Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval
• Questions and Answers on Heparin Sodium Injection (Baxter) (updated)

June 17, 2008

• FDA warns individuals and firms to stop selling fake cancer "cures" FDA News

June 16, 2008

• FDA issues an Information for Healthcare Professionals sheet for antipsychotics. Drug Information
• FDA updates information on adverse event reports and heparin
• New and Generic Drug Approvals
  • Advil Liqui-Gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision
  • Advil Migraine Liqui-Gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision
  • Advil PM (ibuprofen and diphenhydramine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision
  • Advil PM (ibuprofen and diphenhydramine citrate) Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • Butorphanol Tartrate Injection, Apotex Corp., Control Supplement
  • Children's Advil (ibuprofen) Chewable Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • Children's Advil (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
  • Children's Advil - Flavored (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
  • Escitalopram Oxalate Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval
  • Genotropin (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn Co., New or Modified Indication
  • Genotropin Preservative Free (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn Co., New or Modified Indication
  • Irbesartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
  • Junior Strength Advil (ibuprofen) Chewable Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • K-Dur (potassium chloride) Extended-Release Tablets, Schering Corp., Labeling Revision
  • Metoclopramide Hydrochloride Tablets, Ipca Laboratories, Ltd., Approval
  • Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
  • Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
  • Nicorette (Mint) (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
  • Nicorette (Mint) (nicotine polacrilex) Gum, GlaxoSmithKline, Formulation Revision
  • Pediatric Advil (ibuprofen) Oral Drops, Wyeth Consumer Healthcare, Labeling Revision
  • Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Company, LLC, Labeling Revision

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June 19, 2008 Federal Register: Medical Devices; Technical Amendment. Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Slides   June 17, 2008 Office of Science and Engineering Laboratories (OSEL) Fiscal Year 2007 Annual Report

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