November 13, 2009

• FDA issues the following Warning Letters:
  • Charles McKay, MD
  • Eisai, Inc. (Drug Product: Dacogen)
  • Shire Development Inc. (Drug Product: Fosrenol)
  • Hopewell Pharmacy and Compounding Center aka Drugs Are Us, Inc.
• Drug Shortages: Current Drug Shortages: Norpace CR 100 mg and 150 mg capsules
• Information for Healthcare Professionals - Potential Contamination of Products Manufactured by Genzyme Corporation, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
• Information for Healthcare Professionals - Chondrolysis Reported with Continuously Infused Local Anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine)
• Propofol Injection Shortage (updated)

November 12, 2009

• Drugs@FDA Download File (updated)

November 10, 2009

• IABS/FDA co-sponsored Scientific Conference:  Protein Particles and Immunogenicity of Therapeutic Proteins: Filling in the Gaps in Risk Evaluation and Mitigation.  November 12-13, 2009, Bethesda, MD. Meeting and Registration Information.
• FDA approves Istodax (romidepsin) for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma
• MedWatch Alert: Hospira Brand Propofol and Liposyn Products - Recall

November 9, 2009

• Drug Shortages: Current Drug Shortages: Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (updated)
• Guidance for Industry:  E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers

November 13, 2009

• Actiq (fentanyl citrate) Lozenges, Cephalon, Labeling Revision
• Azithromycin Injection, Generamedix, Approval
• Benzonatate Capsules, Mikart, Approval
• Catapres (clonidine hydrochloride) Tablets, Boehringer Ingelheim, Labeling Revision
• Catapres TTS (clonidine) Film, Boehringer Ingelheim, Labeling Revision
• Ciclopirox Topical Cream, Glenmark Pharmaceuticals, Approval
• Cetirizine hydrochloride Syrup, Sun Pharmaceutical Industries, Approval
• Effexor (venlafaxine hydrochloride) Tablets, Wyeth Pharmaceuticals, Labeling Revision
• Geodon (ziprasidone hydrochloride) Capsules, Pfizer, Labeling Revision
• Helidac bismuth subsalicylate; metronidazole; tetracyline hydrochloride Chewable Tablets & Capsules, Prometheus Laboratories, Labeling Revision
• Irinotecan hydrochloride Injection, Ebewe Pharmaceutical, Approval
• Lansoprazole Delayed-Release Capsules, Teva Pharmaceuticals, Approval
• Lotensin (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
• Perindopril erbumine Tablets, Aurobindo Pharmaceutical, Approval
• Perindopril erbumine Tablets, Ivax Pharmaceuticals, Approval
• Perindopril erbumine Tablets, Roxane, Approval
• Plavix (clopidogrel bisulfate) Tablets, Sanofi Aventis, Labeling Revision
• Pristiq (desvenlafaxine succinate) Tablets, Wyeth Pharmaceuticals, Labeling Revision
• Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharmaceuticals, Labeling Revision
• Protonix (pantoprazole sodium) Delayed-Release Tablets, Wyeth Pharmaceuticals, Labeling Revision & Patient Population Altered
• Rebetol (ribavirin) Oral Solution, Schering, Labeling Revision
• Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Labeling Revision
• Soma compound with codeine Tablets, Meda Pharmaceuticals, Labeling Revision
• Tapentadol hydrochloride Tablets, Ortho McNeil Janssen, Labeling Revision
• Tekturna (aliskiren hemifumarate) Tablets, Novartis, Labeling Revision
• Viread (tenofovir disoproxil fumarate) Tablets, Gilread, Labeling Revision
• Zometa (zoledronic acid) Infusion, Novartis, Labeling Revision

November 12, 2009

• Lotensin HCT (benazepril/hydrochlorothiazide) Tablets, Novartis, Labeling Revision
• Pennsaid (diclofenac sodium) Topical Solution, Nuvo Research, Approval

• Indexing Labeling for Human Drug and Biological Products using Structured Product Labeling (SPL). February 2010.
• DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010,  Bethesda, MD. Meeting information and registration.
• 4th Annual FDA/DIA Statistics Forum, April 19-21, 2010, Bethesda, MD. Meeting information and registration.