• FDA issues an FDA Alert and Information for Healthcare Professionals Sheet for Prezista (darunavir ethalolate).
• Paragraph IV Patent Certifications (updated)
• Resolved Drug Shortage: Levothyroxine sodium lyophilized powder for injection

March 20, 2008

• New and Generic Drug Approvals
  • Cefepime Hydochloride Injection, ACS Dobfar, Approval
  • TREANDA (bendamustine hydrochloride) Injection, Cephalon, Approval

March 19, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Benzonatate Capsules, Sun Pharmaceutical Industries, Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Baxter Healthcare, Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Bedford Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Claris Lifesciences Ltd., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hospira Inc., Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Sagent Pharmaceuticals, Approval
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Teva Parenteral Medicines, Inc, Approval
  • Divalproex Sodium Delayed Release Tablets, Zydus Pharmaceuticals, Tentative Approval
  • Fosphenytoin Sodium Injection, Akorn-Strides, LLC, Approval
  • Fosphenytoin Sodium Injection, Sun Pharmaceutical Industries, Inc., Approval
  • Rizatriptan Benzoate Orally Disintegrating Tablets, Mylan Pharmaceuticals, Tentative Approval
  • Symbyax (fluoxetine hydrochloride; olanzapine) Capsules, Eli Lilly and Co., Labeling Revision
     

March 18, 2008

• FDA issues an Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler).
• FDA releases its second issue of the FDA Drug Safety Newsletter.
• FDA releases a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program.
• New and Generic Drug Approvals
  • Isosorbide Dinitrate Extended-release Tablets, CorePharma, Approval
  • Morphine Sulfate Oral Solution, Roxane Labs, Approval
  • Morphine Sulfate Tablets, Roxane Labs, Approval
  • NASAREL (flunisolide) Spray Metered, IVAX Research, Manufacturing Change or Addition
  • Ofloxacin Otic Solution, Alcon, Approval
  • Ofloxacin Otic Solution, Bausch & Lomb, Approval
  • Ofloxacin Otic Solution, Hi-Tech, Approval
  • Ondansetron Hydrochloride and Dextrose in Plastic Container Injection, Claris Lifesciences, Approval
     

March 17, 2008

• New and Generic Drug Approvals
  • ACZONE (dapsone) Gel, QLT Inc., Efficacy Supp. w/Clinical Data
  • Amifostine Injection, Sun Pharma, Approval
  • Azmacort (triamcinolone acetonide) Inhalation Aerosol, Abbott Labs, Labeling Revision
  • Bupropion Hydrochloride Extended-Release Tablets, Actavis, Approval
  • FLOLAN (epoprostenol sodium) Injection, GlaxoSmithKline, Labeling Revision
  • Granisetron Hydrochloride Injection, Wockhardt, Tentative Approval
  • Hydroxyzine Hydrochloride Tablets, InvaGen Pharma, Approval
  • MERREM I.V. (meropenem) Injection, AstraZeneca, Labeling Revision
  • Moban (molindone hydrochloride) Tablets, Endo Pharma, Labeling Revision
  • NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Patient Population Altered
  • Paroxetine Hydrochloride Tablets, Mylan Pharma, Approval
  • SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Manufacturing Change or Addition
  • Tramadol Hydrochloride Tablets, Pliva Inc., Control Supplement
  • Tramadol Hydrochloride Tablets, Pliva Inc., Facility Addition
  • Tramadol Hydrochloride Tablets, Pliva Inc., Manufacturing Revision
     
• Updated phone number for the FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop.

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March 21, 2008 Mammography Facility Adverse Event and Action Report - 2007 Class I Medical Device Recall: Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps   March 20, 2008 Summary Information for: Dako TOP2A FISH pharmDx Kit   March 19, 2008 PMA Final Decisions for February 2008   March 18, 2008 FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx Stent Graft System Medical Devices Dispute Resolution Panel Advisory Meeting, April 19, 2007 - Minutes

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