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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
revision. When viewing a document, click your browser's "refresh" or "reload" button to
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December 14, 2007
- Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection
- Drug Safety Oversight Board Meeting, October 2, 2007: Public Summary
- FDA approves sapropterin (Kuvan) to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
- Guidance for Industry: Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)
- Annex 2:
Test for Extractable Volume of Parenteral Preparations General Chapter [PDF]
- Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter [PDF]
- New and Generic Drug Approvals
- AndroGel (testosterone) Gel, Solvay Pharma, Labeling Revision
- Bleomycin Injection, Pharmachemie B.V., Approval
- Floxin (ofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
- Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
- Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in 5% dextrose) Injection, Ortho-McNeil Pharma, Labeling Revision
- Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
- LEXIVA (fosamprenavir calcium, FPV) Oral Tablets, GlaxoSmithKline, Labeling Revision
- Ranitidine Oral Solution Syrup, Ranbaxy, Approval
- Stavudine Capsules, Emcure Pharma, Tentative Approval 078587
Warning Letter: Effexor XR (venlafaxine HCl) Tablets
December 13, 2007
- The labeling for Exjade (deferasirox) has been changed to include information about postmarketing reports of hepatic failure, some with a fatal outcome. MedWatch Information
- BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
- Current Drug Shortage: Amytal (amobarbital sodium) Injection
- Questions and Answers on Sapropterin (Kuvan)
- New and Generic Drug Approvals
- Aredia (pamidronate disodium) Injection, Novartis Pharma, Labeling Revision
- Ciprofloxacin Extended-release Tablets, Sandoz Inc., Approval
- Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, Hill Dermaceuticals, Patient Population Altered
- Kuvan (sapropterin) Tablets, BioMarin, Approval
- Lamotrigine Tablets, Mylan Pharma, Tentative Approval
- Oxcarbazepine Tablets, Teva Pharma, Approval
- Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
- Sonata (zaleplon) Capsules, King Pharma, Labeling Revision
- Valtrex (valacyclovir hydrochloride) Caplets, GlaxoSmithKline, Labeling Revision
- Vytorin (ezetimibe/simvastatin) Tablets, Merck & Co., Labeling Revision
- Vyvanse (lisdexamfetamine dimesylate) Capsules, New River Pharma, Manufacturing Change or Addition
- Zetia (Ezetimibe) Tablets, Schering Corp., Labeling Revision
December 12, 2007
December 11, 2007
December 10, 2007
December 7, 2007
December 6, 2007
- New and Generic Drug Approvals
- Colgate Total (sodium fluoride & triclosan) Toothpaste, Colgate-Palmolive, Formulation Revision
- Donepezil Hydrochloride Tablets, Ranbaxy, Tentative Approval
- INOmax (nitric oxide) Inhalation, INO Therapeutics Inc., Labeling Revision
- Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
- Omeprazole Delayed-Release Tablets, Dexcel Pharma, Approval
- Phenytoin Sodium Injection, PharmaForce Inc., Approval
- Pregnyl (chorionic gonadotropin) Injection, Organon Inc., Labeling Revision
- REBETOL (ribavirin) Capsules and Oral Solution, Schering Corp., Labeling Revision
- Venofer (Iron Sucrose) Injection, Luitpold Pharma, Labeling Revision
December 5, 2007
December 4, 2007
December 3, 2007
- FDA Launches a Search for
Director, Center for Drug Evaluation and Research (CDER)
- FDA Online Accredited Continuing Educational Module: An Introduction to the Improved FDA Prescription Drug Labeling
- New and Generic Drug Approvals
- Amlodipine Besylate Tablets, Caraco Pharma, Approval
- Atrovent (ipratropium bromide) Nasal Spray, Boehringer Ingelheim, Labeling Revision
- Calcium Acetate Capsules, Roxane Labs, Tentative Approval
- Diovan (valsartan) Tablets. Novartis Pharma, Patient Population Altered
- Granisetron Hydrochloride Injection, Abraxis Pharma, Approval
- Letairis (ambrisentan) Tablets, Gilead Sciences, Labeling Revision
- Metoclopramide Tablets, Northstar Healthcare, Approval
- Ondansetron Oral Solution, Taro Pharma, Approval
- SARAFEM (fluoxetine hydrochloride) Tablets, Warner Chilcott, Labeling Revision
- Tenofovir Disoproxil Fumarate Tablets, Matrix Labs, Tentative Approval
- Triesence (triamcinolone acetonide) Injectable Suspension, Alcon Research, Approval
- Public Meeting on Essential Uses of Ozone Depleting Substances
December 5, 2007, Rockville, MD
November 30, 2007
- Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request
- New and Generic Drug Approvals
- Escitalopram Oxalate Tablets, Caraco Pharma, Tentative Approval
- Haloperidol Tablets, Zydus Pharma, Approval
- Lamivudine and Zidovudine Tablets, Matrix Labs, Tentative Approval
- Mometasone Furoate Topical Solution, Altana Inc., Approval
- Olopatadine Hydrochloride Ophthalmic Solution, Apotex, Tentative Approval
- Oxycodone Hydrochloride and Ibuprofen Tablets, Barr Labs, Approval
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
November 29, 2007
- Drug Shortage: Drug to be Discontinued; Roferon-A (Interferon alfa-2a, Recombinant)
- New and Generic Drug Approvals
- Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules, Eli Lilly & Co., New or Modified Indication
- Epirubicin Hydrochloride Injection, GeneraMedix Inc., Approval
- Granisetron Hydrochloride Injection, Watson Labs, Tentative Approval
- Lactulose Solution, ANI Pharma, Approval
- Ondansetron HCL Oral Solution, Aurobindo Pharma, Approval
- Ropinirole Hydrochloride Tablets, Teva Pharma, Tentative Approval
- Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
November 28, 2007
- Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF]
- Drugs@FDA Downloadable Data Files (updated)
- FDA Acronyms and Abbreviations (updated)
- New and Generic Drug Approvals
- Ciprofloxacin Extended-release Tablets, Anchen Pharma, Approval
- FOSCAVIR (foscarnet sodium) Injection, AstraZeneca, Labeling Revision
- Oxycodone and Acetaminophen Tablets, Interpharm Inc., Approval
- Oxycodone Hydrochloride and Ibuprofen Tablets, Watson Labs, Approval
- Zocor (simvastatin) Tablets, Merck & Co., Labeling Revision
November 27, 2007
- Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed-Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. MedWatch Information.
- New and Generic Drug Approvals
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Watson Labs, Tentative Approval
- Hydrochlorothiazide Capsules, West-ward Pharma, Approval
- Ranitidine Hydrochloride Tablets, Wockhardt, Approval
November 26, 2007
- Manual of Policies and Procedures (MaPP) Gift Certificates/Gift Cards 4636.1R
- New and Generic Drug Approvals
- Bethanechol Chloride Tablets, Amneal Pharma, Approval
- Chantix (varenicline) Tablets, Pfizer Inc., Labeling Revision
- Indocyanine Green for Injection, Pulsion Medical, Approval
- Mometasone Furoate Topical Solution, Tolmar Inc., Approval
- Mometasone Furoate Topical Solution, G&W Labs, Approval
- Motrin IB (ibuprofen) Tablets and Motrin Migraine Pain (ibuprofen) Tablets, McNeil Consumer Healthcare, Labeling Revision
- Omnaris (ciclesonide) Nasal Spray, Nycomed Inc., Approval
- Supprelin LA (histrelin acetate) Subcutaneous Implant, Indevus Pharma, Labeling Revision
- Warning Letter: TYKERB
November 21, 2007
November 20, 2007
November 19, 2007
- FDA updates the FDA Alert and Information for Healthcare Professionals sheet for Avandia
- Manual of Policies and Procedures (MaPP) Accreditation - Continuing Education [PDF]
- New and Generic Drug Approvals
- ABILIFY (aripiprazole) Tablets, Otsuka Pharma, New or Modified Indication
- ABILIFY (aripiprazole) Oral Solution, Otsuka Pharma, New or Modified Indication
- ABILIFY (aripiprazole) Orally Disintegrating Tablets, Otsuka Pharma, New or Modified Indication
- ABILIFY (aripiprazole) Injection Intramuscular, Otsuka Pharma, New or Modified Indication
- Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Daichi Sankyo, Labeling Revision
- Children’s Zyrtec (cetirizine HCl) Chewable Tablets, McNeil Consumer, OTC Approval
- Children’s Zyrtec (cetirizine HCl) Allergy Syrup, McNeil Consumer, OTC Approval
- EMEND (aprepitant) Capsules, Merck & Co. Inc., Labeling Revision
- Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
- Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in 5% dextrose) Injection, Ortho-McNeil Pharma, Labeling Revision
- Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
- Oxcarbazepine Tablets, Taro Pharma, Approval
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca, Approval
- Zyrtec (cetirizine HCl) Tablets, Pfizer, OTC Labeling
November 16, 2007
- Manuals of Policies and Procedures (MaPPs)
- Acceptability of Standards From Alternative Compendia [PDF]
- Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters [PDF]
- New and Generic Drug Approvals
- Avandia (rosiglitazone maleate) Tablets, SB Pharmco, Labeling Revision
- Cefpodoxime Proxetil Tablets, Orchid Healthcare, Approval
- Glyburide and Metformin Hydrochloride Tablets, Aurobindo Pharma, Approval
- Mircera (methoxy polyethylene glycol-epoetin beta) Injection, Hoffman La-Roche, Approval
- Protonix (pantoprazole sodium) Delayed-Release Oral Suspension, Wyeth Pharma, Approval
- Toradol (ketorolac tromethamine) Tablets, Hoffmann-La Roche, Labeling Revision
- Office of Generic Drugs: October First-Time Generic Drug Approvals
- Paragraph IV Patent Certifications (updated)
November 15, 2007
- Drugs@FDA Downloadable Data Files (updated)
- FDA informs healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. MedWatch Safety Information
- BPCA/Pediatric Exclusivity Statistics:
- New and Generic Drug Approvals
- Amoxicillin and Clavulanate Potassium Oral Suspension, Hikma Pharma, Approval
- Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision
- DILAUDID (hydromorphone HCL) Tablets, Abbott Labs, Control Supplement
- KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, New Dosage Regimen
- KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, New Dosage Regimen
- LacHydrin (ammonium lactate) Lotion, Ranbaxy Inc., Labeling Revision
- Lamotrigine Tablets, Caraco Pharma, Tentative Approval
- Losartan Potassium and Hydrochlorothiazide Tablets, Lek Pharma, Tentative Approval
- Theroxidil (minoxidil) Topical Solution, Harmony Labs, Approval
- Pletal (cilostazol) Tablets, Otsuka Pharma, Labeling Revision
November 14, 2007
- Drug Approval Reports
- FDA issues an Early Communication About an Ongoing Safety Review for Cefepime (marketed as Maxipime)
- FDA issues an Information for Healthcare Professionals sheet for Viagra, Levitra, and Cialis
- New and Generic Drug Approvals
- Colgate Total Toothpaste, Colgate-Polmolive, Formulation Revision
- ERAXIS (anidulafungin) for Injection, Vicuron Pharma, Labeling Revision
- Lamotrigine Tablets, Matrix Labs, Tentative Approval
- Lamotrigine Tablets, Watson Labs, Tentative Approval
- Lamotrigine Tablets, Zydus Pharma, Tentative Approval
- Torisel Kit (temsirolimus) Injection, Wyeth Pharma, Package Change
- Zyrtec-D (cetirizine HCl/pseudoephedrine HCl) Tablets, Pfizer Inc., OTC Labeling Revision
November 13, 2007
- Drug Approval Reports: Efficacy Supplement Approvals
- New and Generic Drug Approvals
- Arava (leflunomide) Tablets, Sanofi-Aventis, Labeling Revision
- Crestor (rosuvastatin calcium) Tablets, IPR Pharma, New or Modified Indication
- ELIGARD (leuprolide acetate 45mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision
- ELIGARD (leuprolide acetate 30mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision
- ELIGARD (leuprolide acetate 22.5mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision
- ELIGARD (leuprolide acetate 7.5mg) for Injectable Suspension, Sanofi-Aventis, Labeling Revision
- Lamotrigine Tablets, Sandoz Inc., Tentative Approval
- Optison (Perflutren Protein-Type A Micropheres) Injection, GE Healthcare, Labeling Revision
- SPRYCEL (dasatinib) Tablets, Bristol-Myers Squibb, New Dosage Regimen & Efficacy Supp. w/Clinical Data
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Date revised: December 14, 2007 |
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(updated) 