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What's New by Date
This page lists new and revised documents posted to the CDER web
site. Each listing will remain on this page approximately 30 days. The dates listed
indicate the dates of posting to the CDER web site, not the dates of origination or
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March 11, 2009
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
March 6, 2009
March 5, 2009
- Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Information
- Warning Letters and Untitled Letters to Pharmaceutical Companies
March 4, 2009
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Buspirone Hydrochloride Tablets, Dr. Reddy’s Laboratories Ltd., Approval
- CellCept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision
- CellCept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision
- CellCept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision
- CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision
- Citalopram Hydrobrobromide Tablets, Glenmark Generics Ltd., Approval
- Copaxone (glatiramer acetate) Subcutaneous Solution, Teva Pharmaceuticals USA, New or Modified Indication
- Nabumetone Tablets, Actavis Elizabeth LLC, Approval
- Stavudine, Lamivudine and Nevirapine Tablets, Pharmacare Ltd., Tentative Approval
- Temodar (temozolomide) Injection, Schering Corp., Approval
- Venlafaxine Hydrochloride Extended Release Tablets, Osmotica Pharmaceutical Corp., Package Change
- Zithromax (azithromcyin) Oral Suspension, Pfizer, Inc., Labeling Revision
- Zithromax (azithromycin) Tablets, Pfizer, Inc., Labeling Revision
- Zithromax (azithromycin) Tablets, Pfizer, Inc., Labeling Revision
- Zithromax (azithromycin) Injection, Pfizer, Inc., Labeling Revision
March 3, 2009
- Drug Shortages: Resolved Drug Shortage: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
- Guidance for Industry: Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format [PDF]
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Capozide (captopril and hydrochlorothiazide) Tablets, Bristol-Myers Squibb, Labeling Revision
- Divalproex Sodium Extended-Release Tablets, Anchen Pharmaceuticals (Taiwan), Inc., Approval
- Divalproex Sodium Extended-Release Tablets, Zydus Pharmaceuticals USA Inc., Approval
- Granisetron Hydrochloride Tablets, Dr. Reddy's Laboratories Inc., Approval
- Heparin Sodium 20,000 Units in Dextrose 5% in Plastic Container Injection, B. Braun Medical Inc., Labeling Revision
- Heparin Sodium 1,000 Units in Sodium Chloride 0.9% in Plastic Container Injection, B. Braun Medical Inc., Labeling Revision
- Myoview (technetium tc-99m and tetrofosmin kit) Injection, GE Healthcare, Formulation Revision
- Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Spray, AstraZeneca LP, New or Modified Indication
- Paragraph IV Patent Certifications (updated)
March 2, 2009
February 27, 2009
- Drug Shortages: Current Drug Shortage: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated)
- New and Generic Drug Approvals
- Arthrotec (diclofenac sodium and misoprostol) Delayed-Release Tablets, G.D. Searle, LLC, Labeling Revision
- Baraclude (entecavir) Tablets, Bristol-Myers Squibb Co., Labeling Revision
- Baraclude (entecavir) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision
- Cataflam (diclofenac potassium) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Voltaren (diclofenac sodium) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Voltaren-XR (diclofenac sodium) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
February 26, 2009
- Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
- DDMAC Letter to Pharmaceutical Companies: Avodart (dutasteride) Soft Gelatin Capsules
- New and Generic Drug Approvals
- Carboplatin I.V. Injection, Pharmachemie B.V., Approval
- Exidine (chlorhexidine gluconate) Topical Solution, Xttrium Laboratories, Inc., Package Change
- Ofloxacin Ophthalmic Solution, FDC Ltd., Approval
- Risperidone Oral Solution, Roxane Laboratories, Inc., Tentative Approval
- Office of Nonprescription Products: Listing of OTC Active Ingredients
February 25, 2009
- 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
- Drugs@FDA Downloadable Data Files (updated)
- FDA takes new regulatory action against Ranbaxy’s Paonta Sahib plant in India.
- New and Generic Drug Approvals
- Amoxicillin and Clavulanate Potassium Tablets, Apotex Inc., Approval
- Apidra (insulin glulisine [rDNA origin]) Subcutaneous I.V. Injection, Sanofi Aventis U.S., Inc., Package Change
- Luvox (fluvoxamine maleate) Tablets, Jazz Pharmaceuticals, Labeling Revision
- Luvox CR (fluvoxamine maleate) Extended-Release Capsules, Jazz Pharmaceuticals, Labeling Revision
- Revlimid (lenalidomide) Capsules, Celgene Corp., Labeling Revision
February 24, 2009
- New and Generic Drug Approvals
- Gemcitabine Injection, Hospira, Inc., Tentative Approval
- MembraneBlue (trypan blue) Ophthalmic Solution, Dutch Ophthalmic USA, Approval
- Ranitidine Syrup, Wockhardt Ltd., Approval
- Ranitidine Syrup, Wockhardt Ltd., Tentative Approval
- Roxicodone (oxycodone hydrochloride) Tablets, Xanodyne Pharmaceuticals, Inc., Labeling Revision
February 23, 2009
- Drug Information Association (DIA): Cardiovascular Safety, QT, and Arrhythmia Assessment in Drug Development, April 29-May 1, 2009, Hyatt Regency Besthesda, Bethesda, MD. Meeting information
- Drug Shortages: Current Drug Shortage: Mitomycin for injection
- FDA issues Information for Healthcare Professionals for Zonisamide. Information
- New and Generic Drug Approvals
- Carvedilol Tablets, Hikma Pharmaceuticals, Labeling
- ZANTAC (ranitidine hydrochloride) Syrup, GlaxoSmithKline, Labeling Revision
- ZANTAC 150/300 (ranitidine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- ZANTAC 25/150 (ranitidine hydrochloride) Effervescent Tablets, GlaxoSmithKline, Labeling Revision
February 20, 2009
- New and Generic Drug Approvals
- Cetirizine Hydrochloride Tablets, Orchid Healthcare, Approval
- Colgate Total (sodium fluoride and triclosan)
Dental Paste, Colgate-Palmolive Co., Labeling Revision
- Galantamine Hydrobromide Extended-Release Capsules, IMPAX Laboratories, Inc., Tentative Approval
- Ibuprofen (ibuprofen) Capsules, Banner Pharmacaps, Inc., Labeling Revision
- Implanon (etonogestrel) Implant, Organon USA, Inc., Labeling Revision
- Lamotrigine Chewable Tablets, Glenmark Pharmaceuticals, Ltd., Approval
- Meprobamate Tablets, Alembic, Ltd., Approval
- Nicotine Polacrilex Gum, IVAX Pharmaceuticals, Inc., Approval
- Noxafil (posaconazole) Oral Suspension, Schering Corp., Labeling Revision
- Tenofovir Disoproxil Fumarate Tablets, Aurobindo Pharma, Ltd., Tentative Approval
- Zantac (ranitidine hydrochloride) Injection, GlaxoSmithKline, Labeling Revision
- Zantac in Plastic Container (ranitidine hydrochloride) Injection, GlaxoSmithKline, Labeling Revision
February 19, 2009
- FDA issues Updated Safety Information about Raptiva (efalizumab). Information
- Guidance for Industry: Influenza: Developing Drugs for Treatment and/or Prophylaxis [PDF]
- New and Generic Drug Approvals
- Heparin Sodium Injection, Baxter Healthcare Corp., Labeling Revision
- Rapaflo (silodosin) Capsules, Watson Laboratories, Inc., Package Change
- Revatio (sildenafil citrate) Tablets, Pfizer, Inc., Labeling Revision
- TobraDex ST (tobramycin and dexamethasone) Ophthalmic Suspension, Alcon, Inc., Approval
- TOPROL XL (metoprolol succinate) Extended Release Tablets, AstraZeneca LP, Labeling Revision
- Tracleer (bosentan) Tablets, Actelion Pharmaceuticals, Ltd., Labeling Revision
- Tramadol Hydrochloride Extended-Release Capsules, Willcox & Savage, P.C., Tentative Approval
- Uloric (febuxostat) Tablets, Takeda Pharmaceuticals North America, Inc, Approval
- Zerit (stavudine) Capsules, Bristol-Myers Squibb Co., Labeling Revision
- Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Co., Labeling Revision
February 18, 2009
February 17, 2009
- Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated)
- Drug Shortages: Current Drug Shortage: Acyclovir Injection (updated)
- New and Generic Drug Approvals
- Cipro (ciprofloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
- Cipro (ciprofloxacin) Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
- Cipro in Dextrose 5% in Plastic Container (ciprofloxacin) Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
- Cipro (ciprofloxacin) Oral Suspension, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
- Prograf (tacrolimus) Capsules, Astellas Pharma US, Inc., Labeling Revision
- Prograf (tacrolimus) Injection, Astellas Pharma US, Inc., Labeling Revision
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
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Date updated:
March 11, 2009
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