May 28, 2009

• Guidance for Industry:
  • Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing 
  • Newly Added Bioequivalence Recommendations 21 Newly Added Recommendations.

May 26, 2009

• Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion 
• FDA updates information for stockpiled antivirals at or nearing expiration.

May 20, 2009

• Drug Shortages: Current Drug Shortage: Morphine Sulfate Oral Solution (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA updates information for Tamiflu: Dosing recommendations for infants and technical documents.

May 15, 2009

• Drug Shortages: Current Drug Shortage: Dexrazoxane for Injection, Zinecard

Drug Approvals

• May 29, 2009
  • Adcirca (tadalafil) Tablets, Eli Lilly and Co., Approval
  • Famotidine Tablets, Alembic Limited, Approval
  • Magnevist (gadopentetate dimeglumine) Injection, Bayer HealthCare Pharmaceuticals, Inc., Control Supplement
  • Oxaliplatin Injection, Ebewe Pharma, Tentative Approval
  • Oxaliplatin Injection, Fresenius Kabi Oncology Plc., Tentative Approval
  • Oxaliplatin Injection, Hospira Worldwide PTY, Tentative Approval
  • Oxaliplatin Injection, Sun Pharmaceutical Industries, Ltd., Tentative Approval
  • Oxaliplatin Injection, Teva Parenteral Medicines, Inc., Tentative Approval
  • Phosphocol P 32 (chromic phosphate p 32) Injection, Mallinckrodt, Inc., Labeling Revision
  • Rhinocort (budesonide) Nasal Spray, AstraZeneca Pharmaceuticals, Labeling Revision
  • Sprycel (dasatinib) Tablets, Bristol-Myers Squibb Co., New Dosage Regimen
  • Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Development, Inc., Efficacy Supplement with Clinical Data
  • Vyvanse (lisdexamfetamine dimesylate) Capsules, Shire Development, Inc., Labeling Revision
  • May 27, 2009
    • Ergocalciferol Capsules, Orit Laboratories LLC, Approval 
    • Femring (estradiol acetate) Extended-Release Vaginal Insert, Warner Chilcott, Labeling Revision 
    • Genotropin (somatropin [rDNA origin]) Injection, Pharmacia & Upjohn, Manufacturing Change or Addition
    • Medroxyprogesterone Acetate Injection, Sandoz Canada, Inc., Approval
    • Montelukast Sodium Tablets, Teva Pharmaceuticals, Tentative Approval
    • Sulfacetamide Sodium Lotion, Taro Pharmaceuticals U.S.A., Inc., Approval 
    • Terbutaline Sulfate Injection, Hikma Farmaceutica (Portugal), S.A., Approval
    • Uroxatral (alfuzosin hydrochloride) Extended Release Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision
    • Zestoretic (hydrochlorothiazide and lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
    • Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
    • Zoledronic Acid Injection, PharmaForce, Inc., Tentative Approval

    May 21, 2009

    • Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision
    • Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision
    • Advil Liqui-gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision
    • Calcium Disodium Versenate (edetate calcium disodium) Injection, Graceway Pharmaceuticals, LLC, Labeling Revision
    • Children’s Advil (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
    • Children’s Advil Cold (ibuprofen and pseudoephedrine hydrochloride) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision
    • Junior Strength Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision
    • Prograf (tacrolimus) Capsules, Astellas Pharma US, Inc., Labeling Revision
    • Prograf (tacrolimus) Injection, Astellas Pharma US, Inc., Labeling Revision

    May 20, 2009

    • Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision
    • Nicorette (nicotine polacrilex) Lozenge, GlaxoSmithKline Consumer Healthcare, L.P., Approval
    • Prempro (estrogens, conjugated and medroxyprogesterone acetate) Tablets, Wyeth Pharmaceuticals Inc., Formulation Revision

    May 18, 2009

    • Acarbose Tablets, IMPAX Laboratories, Inc., Approval
    • Adenosine Injection, Strides Arcolab Ltd., Approval
    • Chlorpheniramine Maleate Extended-Release Tablets, Avanthi, Inc., Approval
    • Coly-Mycin M (colistimethate sodium) Injection, JHP Pharmaceuticals, LLC., Labeling Revision
    • Levofloxacin Tablets, Lupin Ltd., Approval
    • Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Tentative Approval
    • Meloxicam Tablets, Strides Arcolab Ltd., Approval
    • Moxifloxacin Hydrochloride Ophthalmic Solution, Teva Parenteral Medicines, Inc., Tentative Approval
    • Quadramet (samarium sm 153 lexidronam pentasodium) Injection, EUSA Pharma Inc., Expiration Date Change
    • Risperdal CONSTA (risperidone) Intramuscular Injection, Johnson & Johnson Pharmaceutical, New or Modified Indication
    • Ropivacaine Hydrochloride Injection, Navinta LLC, Tentative Approval
    • Roxicodone (oxycodone hydrochloride) Tablets, Xanodyne Pharmaceuticals, Inc., Formulation Revision
    • Ursodiol Tablets, TEVA Pharmaceuticals, Approval

• Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information
• Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit, June 10-12, 2009, Hilton Washington DC/Rockville 1750 Rockville Pike, Rockville, MD. Meeting Information
• 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• Quality Risk Management – Implementation Strategies; US FDA/CDER and University of Rhode Island College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency Bethesda, Bethesda, Maryland. Meeting Information.