• Drugs@FDA Downloadable Data Files (updated)
• Inactive Ingredient Search for Approved Drug Products (updated)

July 2, 2008

• New and Generic Drug Approvals
  • Ciprofloxacin Ophthalmic Solution, FDC Ltd., Approval
  • Extended Phenytoin Sodium (phenytoin sodium, extended) Capsules, Sun Pharmaceutical Industries, Ltd., Approval
  • Granisetron Hydrochloride Injection, Apotex Corp., Approval
  • Granisetron Hydrochloride Injection, Abraxis Pharmaceutical Products, Approval
  • Granisetron Hydrochloride Injection, Bedford Laboratories, Approval
  • Granisetron Hydrochloride Injection, Dr. Reddy's Laboratories, Ltd., Approval
  • Granisetron Hydrochloride Injection, Ebewe Parenta Pharmaceuticals, Inc., Approval
  • Granisetron Hydrochloride Injection, Teva Parenteral Medicines, Inc., Approval
  • Granisetron Hydrochloride Injection, Watson Laboratories, Inc., Approval
  • Granisetron Hydrochloride Injection, Wockhardt USA, Inc., Approval
  • Hydroxyzine Hydrochloride Tablets, ANDAPharm, LLC, Approval
  • Risperidone Tablets, TEVA Pharmaceuticals USA, Approval
  • Sterile Vancomycin Hydrochloride Injection, GeneraMedix, Inc., Approval
• Novartis changes sections of Myfortic prescribing information based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic. MedWatch Safety Information
• Public Health Emergency Home Preparation Instructions for Doxycycline
• Sage Products voluntary recalls limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. MedWatch Safety Information
• Warning Letter: Travanti Pharma, Inc.

July 1, 2008

• On June 30, FDA approved the first generic versions of Risperdal (risperidone) tablets to treat schizophrenia, bipolar disorder, and other psychiatric conditions. FDA News
• Clinical Investigator Inspection List (CLIIL)
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• Guidance for Industry:
  • Comprehensive List of Guidance Documents
  • New/Revised/Withdrawn List for 2008
• Manual of Policies and Procedures (MaPP) 6010.8 NDAs and BLAs: Communication to Applicants of Planned Review Timelines
• National Drug Code Directory
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• New and Generic Drug Approvals
  • Acetaminophen Suppository, Actavis Mid Atlantic, LLC, Manufacturing Change or Addition
  • Aciphex (rabeprazole sodium) Delayed-Release Tablets, Eisai Medical Research, Inc., Patient Population Altered
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Amitriptyline Hydrochloride Tablets, Caraco Pharmaceutical Laboratories, Ltd., Approval
  • Betaxolol Hydrochloride Tablets, KVK-Tech, Inc., Approval
  • Dronabinol Capsules, Par Pharmaceutical, Inc., Approval
  • Epoprostenol Injection, GeneraMedix, Inc., Approval
  • Infants' FeverAll (acetaminophen) Suppository, Actavis Mid Atlantic, LLC, Manufacturing Change or Addition
  • Flo-Pred (prednisolone acetate) Oral Suspension, Taro Pharmaceuticals, USA, Inc., Package Change
  • Ganirelix Acetate Injection (ganirelix acetate) Injection, Organon USA, Inc., Labeling Revision
  • Helidac (bismuth subsalicylate, metronidazole and tetracycline hydrochloride) Capsules, Chewable Tablets and Tablets, Prometheus Laboratories, Inc., Labeling Revision
  • Minocin (minocycline hydrochloride) Capsules, Triax Pharmaceuticals, LLC, Labeling Revision
  • Mobic (meloxicam) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Mobic (meloxicam) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Visudyne (verteporfin) Injection, QLT, Inc., Efficacy Supplement with Clinical Data to Support

June 30, 2008

• New and Generic Drug Approvals
  • Adenosine Injection, Bedford Laboratories, Tentative Approval
  • Allegra (fexofenadine hydrochloride) Oral Suspension, Sanofi-Aventis US, LLC, Labeling Revision
  • Allegra (fexofenadine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
  • Anastrozole (anastrozone) Tablets, Sandoz, Inc., Tentative Approval
  • Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Labeling Revision
  • Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Patient Population Altered
  • Famotidine Preservative-Free (famotidine) Injection, Akorn-Strides, LLC, Approval
  • Forteo (teriparatide [rDNA origin]) Subcutaneous Injection, Eli Lilly and Co., Control Supplement
  • Granisetron Hydrochloride Injection, Bedford Laboratories, Approval
  • Lamotrigine Tablets, Cobalt Laboratories, Inc., Tentative Approval
  • Linezolid Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
  • Metvixia (methyl aminolevulinate hydrochloride) Cream, Photocure, ASA, Efficacy Supplement with Clinical Data to Support
  • Sarafem (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
  • Xyzal (levocetirizine dihydrochloride) Oral Solution, UCB, Inc., Labeling Revision
  • Zidovudine Syrup, Cipla, Ltd., Approval

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July 3, 2008 Consumer Information on: XIENCE V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems - P070015 Consumer Information on: Zenith TX2 Thoracic TAA Endovascular Graft with the H&LB One-Shot Introduction System - P070016   July 2, 2008 FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff   July 1, 2008 FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

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