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April 3, 2008

• New and Generic Drug Approvals
  • Dibenzyline (phenoxybenzamine hydrochloride) Capsules, WellSpring Pharmaceutical, Labeling Revision
  • Phenergan Fortis (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition
  • Phenergan Plain (promethazine hydrochloride) Syrup, ANI Pharma, Manufacturing Change or Addition
  • Phenergan with Dextromethorphan (promethazine hydrochloride, dextromethorphan hydrobromide) Syrup, ANI Pharma, Manufacturing Change or Addition

April 2, 2008

• CDER Data Standards Manual: SPL Flavor
• Resolved Drug Shortage: BiCNU
• Drugs@FDA Downloadable Data Files (updated)
• GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports. MedWatch Safety Information
• Meeting: A Joint FDA/URI College of Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June 30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD. Meeting Information [External Site]
• New and Generic Drug Approvals
  • Diflucan (fluconazole) Tablets, Pfizer Inc., Labeling Revision
  • Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer Inc., Labeling Revision
  • Diflucan in Sodium Chloride 0.9% (fluconazole) Injection, Pfizer Inc., Labeling Revision
  • Diflucan in Sodium Chloride 0.9% in Plastic Container (fluconazole) Injection, Pfizer Inc., Labeling Revision
  • Diflucan (fluconazole) for Oral Suspension, Pfizer Inc., Labeling Revision
  • Inderal (propranolol hydrochloride) Injection, Baxter Healthcare, Labeling Revision
  • Lotronex (alosetron hydrochloride) Tablets, Prometheus Labs, New Dosage Regimen
  • Phentermine Hydrochloride Tablets, KVK-Tech Inc., Approval
• Novartis will no longer make Zelnorm available under a treatment IND protocol.

April 1, 2008

• International Conference on Harmonization (ICH) Preparation for ICH meetings in Portland, Oregon, Rockville, MD, April 4, 2008. Meeting Information
• New and Generic Drug Approvals
  • Avodart (dutasteride) Soft Gelatin Capsule, GlaxoSmithKline, Labeling Revision
  • ANTHELIOS 40 (avobenzone, ecamsule, octocrylene and titanium dioxide) Cream, Loreal, Approval
  • Hydroxyzine Hydrochloride Tablets, Northstar Healthcare, Approval
  • Metronidazole in Plastic Container Injection, Claris LifeSciences, Approval
  • Xyzal (levocetirizine dihydrochloride) Tablets, UCB Inc., Labeling Revision
• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft)
• Warning Letter: Inspection; West Jefferson Medical Center IRB

March 31, 2008

• Guidance for Industry: Comprehensive List of Guidance Documents and New/Revised/Withdrawn List for 2008
• New and Generic Drug Approvals
  • AMOXIL (amoxicillin) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Tablets, Capsules, GlaxoSmithKline, Labeling Revision
  • AMOXIL (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
  • Lamotrigine Tablets, Taro Pharma, Tentative Approval
  • Primaxin I.V. (Imipenem and Cilastatin) Injection, Merck & Co., Labeling Revision
  • Primaxin I.M. (Imipenem and Cilastatin) Injectable Suspension, Merck & Co., Labeling Revision
  • Rifampin Capsules, Lannett, Approval

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