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Center for Drug Evaluation &
Research (CDER) News

• Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products (updated)
• New and Generic Drug Approvals
  • Cefazolin Sodium Injection, Cephazone Pharma, LLC, Approval
  • Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly and Co., Labeling Revision
  • Divalproex Sodium Delayed-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Fluoxetine Capsules, Alembic Limited, Approval
  • Minocycline Hydrochloride Extended-Release Tablets, Barr Laboratories, Inc., Approval
  • Pantoprazole Sodium Delayed-Release Tablets, KUDCO Ireland Limited, Approval
  • Prozac (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support
  • Prozac (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
  • Tracleer (bosentan) Tablets, Actelion Pharmaceuticals, Ltd., Labeling Revision
  • Symbyax (olanzapine and fluoxetine) Capsules, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support
  • Zyprexa (olanzapine) Tablets, Eli Lilly and Co., Efficacy Supplement with Clinical Data To Support
  • Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Co., Efficacy Supplement with Clinical Data to Support

March 19, 2009

• Drug Firm Annual Registration Status Query (updated)
• FDA issues Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens. Information
• Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment [PDF]
• National Drug Code Directory (updated)

March 18, 2009

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Divalproex Sodium Extended-Release Tablets, Teva Pharmaceuticals, Tentative Approval
  • Humalog (insulin lispro (rDNA origin)) Injection, Eli Lilly and Company, Control Supplement
  • Humalog Mix 75/25 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Company, Control Supplement
  • Humalog Mix 50/50 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Company, Control Supplement
  • Humulin N (insulin susp isophane [rDNA origin]) Injection, Eli Lilly and Company, Control Supplement
  • Humulin 70/30 (insulin [rDNA origin] and susp isophane [rDNA origin]) Injection, Eli Lilly and Company, Control Supplement
  • Lamivudine Tablets, Alkem Laboratories Ltd., Tentative Approval
  • Lexiscan (regadenoson) Intravenous Solution, Astellas Pharma US, Inc., Labeling Revision
  • Omeprazole Delayed-Release Capsules, Dr. Reddy's Laboratories Ltd., Approval
  • Ultram ER (tramadol hydrochloride) Extended Release Tablets, Bioavail Laboratories International SRL, Manufacturing Change or Addition

March 17, 2009

• New and Generic Drug Approvals
  • Apraclonidine Hydrochloride Ophthalmic Solution, Akorn, Inc., Approval
  • Cosmegen (dactinomycin) Injection, Ovation Pharmaceuticals. Inc., Labeling Revision
  • Children’s Zyrtec Allergy (cetirizine hydrochloride) Syrup, McNeil Consumer Healthcare, Package Change
  • Edluar (zolpidem tartrate) Tablets, Orexo AB, Sweden, Approval
  • Eloxatin (oxaliplatin) I.V. Injection, Sanofi-Aventis U.S., Labeling Revision
  • Eloxatin (oxaliplatin) I.V. Injection, Sanofi-Aventis U.S., Labeling Revision
  • Humatrope (somatropin [rDNA origin]) Injection, Eli Lilly and Co., New or Modified Indication
  • Ixempra Kit (ixabepilone) I.V. Injection, Bristol-Myers Squibb Co., Control Supplement
  • Levetiracetam Tablets, Apotex Inc., Approval
  • Metronidazole Tablets, Alembic Ltd., Approval
  • Promethazine Hydrochloride Syrup , SuN Pharmaceutical Industries, Inc., Approval
  • Reclast (zoledronic acid) I.V. Injection , Novartis Pharmaceuticals Corp., New or Modified Indication

March 16, 2009

• Drug Shortages: Current Drug Shortage: Triamcinolone Hexacetonide (Aristospan)
• Paragraph IV Patent Certifications (updated)

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Approval Information - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix) - Update
Posted: 3/20/2009

Urgent Instruction Correction: Biotest Tango Automated Blood Bank Analyzer - Biotest AG-Dreieich
Posted: 3/19/2009

Vacancy Announcement - Program Assistant, OM
Posted: 3/17/2009

Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications
Posted: 3/16/2009

Public Workshop: Clinical Trials Endpoints for Acute Graft-versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Posted: 3/16/2009; Meeting Date: 5/19/2009

Medical Device Recall (PR09-0082-0): Cerner PathNet Blood Bank Donor, Cerner Corporation
Posted: 3/16/2009

Blood Products Advisory Committee: April 1-2, 2009 Meeting
Posted: 3/16/2009

Alphabetical List of Licensed Establishments - Update
Posted: 3/16/2009

Current Licensed Establishments and Products Listed by Product - Update
Posted: 3/16/2009

Approved Premarket Approval (PMA) Device Applications - Update
Posted: 3/16/2009

Substantially Equivalent 510(k) Device Applications - Update
Posted: 3/16/2009

Approved NDA and ANDA Applications - Update
Posted: 3/16/2009

Approval Information - Pneumococcal 7 - valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar) - Package Insert
Posted: 3/16/2009

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