February 13, 2009

• CDER Organization Charts [HTML] [PDF] (updated)

• Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions

  • Annex 6: Uniformity of Dosage Units General Chapter [PDF]

  • Annex 7: Dissolution Test General Chapter [PDF]

  • Annex 8: Sterility Test General Chapter [PDF]

• Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals [PDF]

• Drug Shortages: Resolved Drug Shortage: Alprostadil 0.5 mg/mL injection

• Medication Guides web page (updated)

• New and Generic Drug Approvals

  • Doribax (doripenem) I.V. Injection, Johnson & Johnson Pharmaceutical Research & Development, LLC., Labeling Revision

  • Floxin (ofloxacin) Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC., Labeling Revision

  • Fludara (fludarabine phosphate) Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision

  • Fludarabine Phosphate Injection, Actavis Totowa, LLC, Approval

  • Galantamine Hydrobromide Tablets, Roxane Laboratories, Inc., Approval

  • Keppra XR (levetiracetam) Extended-Release Tablets, UCB, Inc., Formulation Revision

  • Lamotrigine Tablets, Matrix Laboratories, Ltd., Approval

  • Levofloxacin Injection, Hospira, Inc., Tentative Approval

  • Levofloxacin and Dextrose Injection, Hospira, Inc., Tentative Approval

  • Lysodren (mitotane) Tablets, Bristol-Myers Squibb Co., Labeling Revision

  • Noroxin (norfloxacin) Tablets, Merck & Co., Inc., Labeling Revision

  • Novantrone (mitoxantrone hydrochloride) Injection, EMD Serono, Inc., Labeling Revision

  • Toprol-XL (metoprolol succinate) Extended Release Tablets, AstraZeneca, LP, Labeling Revision

  • Totect (dexrazoxane hydrochloride) Injection, Regulus Pharmaceutical Consulting, Inc., Labeling Revision

  • Xenical (orlistat) Capsules, Hoffmann-La Roche, Inc., Labeling Revision

• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Final)

• Standard Costs for Components of the Process for the Review of Human Drug Applications (updated)

February 12, 2009

• Forum - Cytokine Therapies: Novel Approaches for Clinical Indications, March 26 and 27, 2009, NYAS Conference Center, New York City, NY: This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Meeting Information.

• Drug Safety Oversight Board Meeting, January 15, 2009

• Drug Shortages: Current Drug Shortage: Amikacin sulfate injection

• Drug Shortages: Current Drug Shortage: Azactam 1 gram and 2 gram (aztreonam for injection)

• Drug Shortages: Current Drug Shortage: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg)

• Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30 mg)

• New and Generic Drug Approvals

  • Casodex (bicalutamide) Tablets, AstraZeneca Pharmaceuticals, LP, Labeling Revision

  • CEDAX (ceftibuten) Capsules, Shionogi USA, Inc., Labeling Revision

  • CEDAX (ceftibuten) Oral Suspension, Shionogi USA, Inc., Labeling Revision

  • CUBICIN (daptomycin) Injection, Cubist Pharmaceuticals, Inc., Labeling Revision

  • Divalproex Sodium Extended-release Tablets, Wockhardt Limited, Approval

  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceutical Corp., Labeling Revision

  • Levetiracetam Oral Solution, Taro Pharmaceutical Industries, Ltd., Approval

  • Levetiracetam Tablets, Genpharm ULC, Approval

  • Levetiracetam Tablets, Solco Healthcare LLC, Approval

  • Survanta (beractant) Intratracheal Suspension, Abbott Laboratories, Labeling Revision

February 11, 2009

• Drugs@FDA Downloadable Data Files (updated)

• New and Generic Drug Approvals

  • Altace (ramipril) Capsules, King Pharmaceuticals, Inc., Labeling Revision

  • Altace (ramipril) Tablets, King Pharmaceuticals, Inc., Labeling Revision

  • Furadantin (nitrofurantoin) Oral Suspension, Sciele Pharma, Inc., Labeling Revision

  • Monopril (fosinopril sodium) Tablets, Bristol-Myers Squibb, Labeling Revision

  • Monopril HCT (fosinopril and hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision

  • Sumatriptan Succinate Injection, Bedford Laboratories, Approval

  • Sumatriptan Succinate Injection, Sandoz Canada, Inc., Approval

  • Sumatriptan Succinate Tablets, Ranbaxy Laboratories Limited, Approval

  • Sumatriptan Succinate Tablets, TEVA Pharmaceuticals, Approval

  • Tasmar (tolcapone) Tablets, Valeant Pharmaceuticals International, Labeling Revision

  • Tygacil (tigecycline) Injection, Wyeth Pharmaceuticals, Inc., Labeling Revision

• PQRI Workshop: Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products, March 9-10, 2009, Hyatt Regency Bethesda, Bethesda, MD. Program and registration

February 10, 2009

• New and Generic Drug Approvals

  • Entereg (alvimopan) Capsules, Adolor Corp., Labeling Revision

  • Galantamine Hydrobromide Tablets, Par Pharmaceutical, Inc., Approval

  • Ibuprofen Tablets, Shasun USA, Inc., Approval

  • Sumatriptan Succinate Injection, TEVA Parenteral Medicines, Approval

  • Sumatriptan Succinate Injection, Wockhardt USA, Inc., Approval

February 9, 2009

• BPCA/Pediatric Exclusivity Statistics (updated)

• Drug Shortages: Current Drug Shortage: Acyclovir Injection

• Drug Shortages: Current Drug Shortage: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules
  (NDC 00089-0510-06)

• FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop, April 23, 2009. Meeting Information and registration

• FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

• New and Generic Drug Approvals

  • Lamotrigine Chewable Tablets, Taro Pharmaceutical Industries, Ltd., Approval

  • Lamotrigine Tablets, Upsher-Smith Laboratories, Inc., Approval

  • OxybutyninChloride Extended-release Tablets, Osmotica Pharmaceutical Corp., Approval 

  • Stavzor (valproic acid) Delayed-Release Capsules, Banner Pharmacaps Inc., Package Change

FDA Patient Safety News - A Video News Show for Health Professionals

This Week Rule Changes:
21 CFR Parts - 520 - 522 - 510 - 528 - 314 - 520

CFR Changes since April 1st.

Thursday, Feb. 19, 2009

Wed. Feb. 18, 2009

Tuesday, Feb. 17, 2009

Monday, Feb. 16, 2009

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