March 13, 2009

• 3rd Annual FDA/DIA Statistics Forum: Emerging and Strategic Issues in Drug Development, Personalized Medicine, and a Guidance Update, April 26, 2009, Westin Arlington Gateway, Arlington, VA 22203. Meeting Information

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated)

• Guidance for Industry: Newly Added Bioequivalence Recommendations.

• New and Generic Drug Approvals

  • Levaquin (levofloxacin) Tablets, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision

  • Levaquin (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision

  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision

  • Levaquin (levofloxacin) Oral Solution, Ortho McNeil-Janssen Pharmaceutical, Inc., Labeling Revision

  • Lopinavir and Ritonavir Tablets, Matrix Laboratories, Ltd., Tentative Approval 

  • Lopinavir and Ritonavir Tablets, Aurobindo Pharma, Ltd., Tentative Approval

  • Norditropin (somatropin [rDNA origin]) Injection, Novo Nordisk, Inc., Control Supplement

  • Pamidronate Disodium Injection, GeneraMedix, Inc., Approval

  • Prednisolone Sodium Phosphate Oral Solution, Amneal Pharmaceuticals, Approval

  • Rocephin (ceftriaxone sodium) Intramuscular I.V. Injection, Hoffmann-La Roche, Inc., Labeling Revision

  • Vancocin Hydrochloride in Plastic Container (vancomycin hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision

March 12, 2009

• Drug Shortages: Current Drug Shortage: Metoprolol succinate extended release tablets (updated)

March 11, 2009

• March 3rd Industry Meeting: Information and Presentations

• Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia Public Workshop, March 31, 2009 and April 1, 2009, Silver Spring, Maryland. Public Workshop Information (updated)

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

• Drugs@FDA Downloadable Data Files (updated)

• Manual of Policies and Procedures (MaPPs):

  • 5310.9 Acceptance Criteria for Residual Solvents

  • 6010.9 Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments

March 10, 2009

• FDA issues position on allowing patients with ALS access to Iplex under an IND

• New and Generic Drug Approvals

  • Epzicom (abacavir sulfate and lamivudine) Tablets, GlaxoSmithKline, Labeling Revision

  • Indomethacin Extended-Release Capsules, Avanthi, Inc., Approval

  • Ketorolac Tromethamine Ophthalmic Solution, Alcon, Inc., Tentative Approval

  • Leuprolide Acetate Injection, Sun Pharma Global, Inc., Approval

  • Malathion Lotion, Synerx Pharma, LLC, Approval

  • Mevacor (lovastatin) Tablets, Merck & Co., Inc., Control Supplement

  • Propranolol Hydochloride Extended-Release Capsules, Upsher-Smith Laboratories, Inc., Approval

  • Ramipril Capsules, Ranbaxy Laboratories Ltd., Approval

  • Rosiglitazone Maleate Tablets, Sandoz Inc., Tentative Approval

  • Sustiva (efavirenz) Capsules, Bristol-Myers Squibb Co., Labeling Revision

  • Sustiva (efavirenz) Tablets, Bristol-Myers Squibb Co., Labeling Revision

  • Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets, GlaxoSmithKline, Labeling Revision

  • Zithromax (azithromycin) Oral Suspension, Pfizer, Inc., Labeling Revision

  • Zithromax (azithromycin) Tablets, Pfizer, Inc., Labeling Revision

• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

March 9, 2009

• BPCA/Pediatric Exclusivity Statistics (updated)

• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

• New and Generic Drug Approvals

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

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

  • Demerol (meperidine hydrochloride) Tablets and Oral Solution, Sanofi Aventis U.S., Labeling Revision

  • Diabeta (glyburide) Tablets, Sanofi-Aventis U.S. LLC, Labeling Revision

  • Divalproex Sodium Delayed-Release Tablets, Zydus Pharmaceuticals USA Inc., Approval

  • Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision

  • Glycopyrrolate Tablets, West-ward Pharmaceutical Corp., Approval

  • Macrobid (nitrofurantoin monohydrate and macrocrystals) Capsules, Proctor & Gamble Pharmaceuticals, Inc., Labeling Revision

  • Macrodantin (nitrofurantoin monohydrate and macrocrystals) Capsules, Proctor & Gamble Pharmaceuticals, Inc., Labeling Revision

  • Methylprednisolone Acetate Injection, Sandoz Canada, Inc., Approval

  • Quinapril Hydrochloride and Hydrochlorothiazide Tablets, Ranbaxy Laboratories Ltd., Approval

  • Sertraline Hydrochloride Tablets, AustraPharma, LLC, Approval

  • SPORANOX (itraconazole) Capsules, Johnson & Johnson Pharmaceutical Research and Development, Labeling Revision

  • SPORANOX (itraconazole) Injection, Johnson & Johnson Pharmaceutical Research and Development, Labeling Revision

  • SPORANOX (itraconazole) Oral Solution, Johnson & Johnson Pharmaceutical Research and Development, Labeling Revision

  • Tarka (trandolopril and verapamil hydrochloride) Extended-Release Tablets, Abbott Laboratories, Inc., Labeling Revision

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

This Week Rule Changes:
21 CFR Parts -
73 - 101 - 520 - 529

CFR Changes since April 1st.

Friday, March 13, 2009

Thursday, March 12, 2009

Wednesday. March 11, 2009

Tuesday, March 10, 2009

Monday, March 09, 2009

NOTICES
Agency Information Collection Activities; Proposals, Submissions, and Approvals
10052–10053 [E9–4829]   [TEXT]  [PDF]
10053–10055 [E9–4830]   [TEXT]  [PDF]

Determination of Regulatory Review Periods for Purposes of Patent Extension:
     Altabax Ointment
     10055–10056 [E9–4914]   [TEXT]  [PDF]