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 make sure you are seeing the latest version. 

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November 17, 2004

• First Action Performance Reports (FY Cohort Closeout Stats)

  • First Action Performance For Original Manufacturing Supplements
  • First Action Performance For Original Efficacy Supplements
  • First Action Performance For Original NDAs
  • First Action Performance For Resubmitted NDAs
  • First Action Performance For Resubmitted Efficacy Supplements
• New and Generic Drug Approvals
  • Carboplatin Injection, Pliva-Lachema, Approval
  • Citalopram Hydrobromide Tablets, Ivax Pharma, Approval
  • Propoxyphene Napsylate & Acetaminophen Tablets, Andrx, Approval
• Orange Book: Query
• Orange Book: Cumulative Supplement No 10
• Orange Book: Information and Data Files
• Orange Book: Monthly Additions and Deletions
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
  • Pamine (methscopolamine bromide)

November 16, 2004

• Consumer Information Sheet: Campral

• New and Generic Drug Approvals
  • Altace (ramipril) Capsules, King Pharmaceuticals, Labeling Revision
  • Benicar (olmesartan medoxomil) Tablets, Sankyo Pharma Inc., Labeling Revision
  • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets, Sankyo Pharma Inc., Labeling Revision
  • Lorazepam Injection, International Medication Systems, Approval
  • MIFEPREX (mifepristone) Tablets, Danco Laboratories, Labeling Revision
  • Pilocarpine Hydrochloride Tablets, Corepharma, Approval
  • Singulair (montelukast sodium) Tablets, Merck & Co., Inc., Labeling Revision
  • Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Inc., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck & Co., Inc., Labeling Revision
  • Tabloid (thioguanine) Tablets, SmithKlineBeecham, Labeling Revision
  • Zomig (zolmitriptan) Tablets, AstraZeneca Pharma, Patient Population Altered

November 15, 2004

• FDA announces important labeling changes for Mifeprex (mifepristone, also known as RU-486). Mifeprex Information.
• New and Generic Drug Approvals
  • Citalopram Hydrobromide Tablets, Caraco Pharma, Approval
  • Omacor (Omega-3-Acid Ethyl Esters) Capsules, Abbott, Approval
  • Paclitaxel Injection, SuperGen, Inc., Approval
  • Sotradecol (Sodium Tetradecyl Sulfate) Injection, Bioniche Pharma, Approval
• Pediatric Exclusivity Labeling Changes (updated)
• Prescription Drug User Fee Act (updated)
  • The FY 2004 "cleanup" invoices were mailed out November 15, 2004. The payments are due to FDA by December 15, 2004. If you didn't get an invoice, and you have a new product or establishment approved during FY 2004, please contact the user fee staff.
  • The phone number to obtain a UFID number for CDER applications and supplements has been changed. Please call 301-210-2880 for assignment of a UFID number.
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
  • Tramadol
  • Viagra

November 12, 2004

• Drug Shortage: Current; Methotrexate Injection
• FDA approves first-time generic Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for the treatment of small uncomplicated varicose veins of the lower extremities. The reference listed drug is Sotradecol Injection.

November 10, 2004

• CDER Key Officials

• Drug Approval Reports

  • FY 2004 Priority Approvals
  • FY 2004 User Fee NME Drug and New Biologic Approvals

  • NDA Approval Rates for Standard NDAs Received FY 93-03 and Approved within 36 Months

  • NDA Approval Rates for Priority NDAs Received FY 93-03 and Approved within 36 Months

• New and Generic Drug Approvals
  • Augmentin ES-600 (amoxicillin/clavulanate potassium) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • Delsym (dextromethorphan polistirex) Extended-Release Suspension, Celltech Pharma, Formulation Revision
  • Humulin 70/30 Injection, Eli Lilly, Labeling Revision
  • MIOSTAT (carbachol intraocular solution), Alcon, Labeling Revision
  • Naprosyn (naproxen) Tablets, Roche Palo Alto, Labeling Revision
  • Anaprox/Anaprox DS (naproxen sodium) Tablets, Roche Palo Alto, Labeling Revision
  • Naprosyn (naproxen) Suspension, Roche Palo Alto, Labeling Revision
  • EC-Naprosyn (naproxen) Delayed Release Tablets, Roche Palo Alto, Labeling Revision
  • Omacor (omega-3-acid ethyl esters) Capsules, Ross Products, Approval
• BPCA/Pediatric Exclusivity Statistics 
  • Breakdown of Requested Studies Report (updated)
  • Written Requests Issued (updated)
  • Pediatric Exclusivity Statistics (updated)
  • Spectrum of Diseases/Conditions  (updated)
• Vioxx (rofecoxib): Slide Presentation by Sandra Kweder, M.D., November 10, 2004. [HTML]  [PowerPoint]

November 9, 2004

• Drug Shortage: Current; Folic Acid injection

November 8, 2004

• FDA and Abbott Pharmaceuticals notify healthcare professionals of revisions to the WARNINGS section of the prescribing information for Humira (adalimumab), indicated for the treatment of rheumatoid arthritis. MedWatch Safety Info.
  
• New and Generic Drug Approvals
  • Canasa (Mesalamine, USP) Rectal Suppositories, Axcan Scandipharm, New Dosage Regimen
  • Citalopram Hydrobromide Tablets, Alphapharm, Approval
  • Citalopram Hydrobromide Tablets, Watson Labs, Approval
  • Citalopram Hydrobromide Tablets, Kali Labs, Approval
  • Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision
  • Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision
  • Phenergan (promethazine HCl) Suppositories, Wyeth Pharma, Labeling Revision
  • Robinul (glycopyrrolate for injection, USP) Injection, Baxter Healthcare, Labeling Revision
  • Striant (testosterone buccal system) mucoadhesive, Columbia Lab, Control Supplement
  • Trecator (ethionamide tablets, USP) Tablets, Wyeth Pharma, Manufacturing Change or Addition & Formulation Revision
  • Tricor (fenofibrate) Tablets, Abbott, Approval

November 5, 2004

• Manual of Policies and Procedures: 4151.2 Documenting Differing Professional Opinions and Dispute Resolution – Pilot Program
• New and Generic Drug Approvals
  • Ciprofloxacin Tablets, Apotex Inc., Approval
  • Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma, Labeling Revision
  • Eloxatin (Oxaliplatin) Injection, Sanofi-Synthelabo, New or Modified Indication
• Office of Generic Drugs (updated)
  • Approvals
  • First-Time Generics
  • Tentative Approvals

November 4, 2004

• New and Generic Drug Approvals
  • LEVAQUIN (levofloxacin) Tablets, Ortho McNeil Pharma, Labeling Revision
  • LEVAQUIN (levofloxacin) Injection, Ortho McNeil Pharma, Labeling Revision
  • Orvaten (Midodrine Hydrochloride) Tablets, Upsher-Smith Labs, Approval
  • Pioglitazone Hydrochloride Tablets, Mylan Pharma, Tentative Approval
  • Soriatane (acitretin) Capsules, Connetics Corp., Labeling Revision
  • Topiramate Tablets, Teva Pharma, Tentative Approval 076317
  • Tylenol Arthritis Pain Extended release tablets, McNeil Consumer, Package Change
  • ZYBAN (bupropion hydrochloride), GlaxoSmithKline, Labeling Revision

November 3, 2004

• Guidance Documents

  • Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 -- Questions and Answers [HTML] or [Word] or [PDF]. (Issued 10/2004, Posted 11/3/2004)

• New and Generic Drug Approvals
  • Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision
  • Cordarone (amiodarone HCl) Intravenous, Wyeth Pharma, Labeling Revision
  • Felodipine Extended-Release Tablets, Mutual Pharma, Approval
  • Loxapine Capsules, Mylan Pharma, Approval
  • Megestrol Acetate Oral Suspension, Morton Grove, Approval
  • Norditropin Cartridges (somatropin [rDNA origin]) injection, Novo Nordisk, New or Modified Indication
  • Restoril (temazepam) Capsules, Mallinckrodt Inc., Manufacturing Change or Addition
  • Saizen (somatropin [rDNA origin]) Injection, Serono, Inc., New or Modified Indication
  • Today (1 gram nonoxynol- 9 vaginal contraceptive) Sponge, Allendale Pharmaceuticals, Labeling Revision

• The FDA has written a proposed Medication Guide about Using Antidepressants in Children or Teenagers and sent this Medication Guide to all the sponsors on October 21, 2004. To inform other groups and individuals with an interest in this Medication Guide, it has also been linked to the Antidepressants web page. The FDA hopes to finalize the language of this Medication Guide by December 2004 so that the Medication Guide can be produced and made available to patients by the end of January 2005.

November 2, 2004

• CDER Organization Charts
  • Center for Drug Evaluation Research Organizational Chart
  • Office of Center Director
  • Office of Management
  • Office of Pharmaceutical Sciences
  • Office of Pharmacoepidemiology and Statistical Science 
  • Office of New Drugs
• Drug Approval Reports
  • FY 2004 Priority Approvals (updated)
  • FY 2004 User Fee NME Drug and New Biologic Approvals (updated)
• Office of Generic Drugs (updated)
  • Approvals
  • First-Time Generics
  • Tentative Approvals
  • Paragraph IV Patent Certifications
• Vioxx: 9/30/2004 Study Report
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies: Kaletra (lopinavir/ritonavir) Capsules and Oral Suspension
  • Promotional Material

November 1, 2004

• New and Generic Drug Approvals
  • Albuterol sulfate HFA Inhalation Aerosol, IVAX Research, Approval
  • Femara (Letrozole) Tablets, Novartis Pharma, New or Modified Indication
  • Menopur (menotropins) Injection, Ferring Pharma, Approval

October 29, 2004

• Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (updated)
• Drug Shortage: Resolved; Amphadase (hyaluronidase) injection, USP, 150 IU mL
• FDA approves five first-time generics for Citalopram Hydrobromide Tablets, 10 mg (base), 20 mg (base) and 40 mg (base) to treat depression. The reference listed drug is Celexa.
• New and Generic Drug Approvals
  • Bethanechol Chloride Tablets, Amide Pharma, Approval
  • Bethanechol Chloride Tablets, Amide Pharma, Approval
  • Bethanechol Chloride Tablets, Amide Pharma, Approval
  • Bethanechol Chloride Tablets, Amide Pharma, Approval
  • Carboplatin Injection, Mayne Pharma, Approval
  • Cenestin (synthetic conjugated estrogens, A) Tablets, Duramed Pharma, Labeling Revision
  • Citalopram Hydrobromide Tablets, Eon Labs, Approval
  • Citalopram Hydrobromide Tablets, Dr. Reddy’s Labs, Approval
  • Citalopram Hydrobromide Tablets, CorePharma, Approval
  • Citalopram Hydrobromide Tablets, Aurobindo Pharma, Approval
  • Citalopram Hydrobromide Tablets, Purepac Pharma, Approval
  • Claritin (loratadine) Syrup, Schering Corp., Control Supplement
  • Doxil (doxorubicin HCl liposome) injection, Johnson & Johnson Pharma, Efficacy Supplement with Clinical Data to Support
  • Enalapril Maleate & Hydrochlorothiazide Tablets, Apotex, Approval
  • Lithium Carbonate Extended-Release Tablets, Roxane Labs, Approval
  • Pepcid AC Film Coated (famotidine) Tablets, Merck Research, Labeling Revision
  • Pepcid AC Chewable (famotidine) Tablets, Merck Research, Labeling Revision
  • Pepcid AC Gelcaps (famotidine) Capsules, Merck Research, Labeling Revision
  • Pepcid Complete Tablets, Merck Research, Labeling Revision
  • Protonix I.V. (pantoprazole) Injection, Wyeth Pharma, Control Supplement
  • Sodium Chloride Injection, Haemonetics Corp., Approval
  • Testosterone Gel, Paddock Labs, Tentative Approval
  • Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
• Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling [HTML] or [Word] or [PDF]

October 28, 2004

• Division of Metabolic and Endocrine Drug Products (updated)

• Drug Approval Reports

  • Fast Track Designated Products Approved since 1998 (updated) 
  • CDER Response to Request for Fast Track Designation  (updated)
• Online Tutorial - Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)
• Postmarketing Study Commitments (updated)

October 27, 2004

• New and Generic Drug Approvals
  • Amphadase (hyaluronidase injection, USP), Amphastar Pharma, Approval
  • Axid AR (nizatidine) Tablets, Wyeth Consumer, Labeling Revision
  • Cuprimine (penicillamine) Capsules, Merck & Co., Inc., Labeling Revision
  • Finasteride Tablets, Teva Pharmaceuticals, Tentative Approval
  • FOSRENOL (lanthanum carbonate) Chewable Tablets, Shire Pharma, Approval
  • Keppra (levetiracetam) Tablets, UCB Pharma, Inc., Labeling Revision
  • Keppra (levetiracetam) Oral Solution, UCB Pharma, Inc., Labeling Revision
  • (Lidocaine HCl 2% and Epinephrine 1:100,000 Solution for Topical Iontophoretic System), Empi, Inc., Approval
  • Medroxyprogesterone Acetate Injectable Suspension, Sicor Pharma, Approval

October 26, 2004

• FDA, Janssen Pharmaceutica Products, and Johnson & Johnson Pharmaceutical Research & Development notify healthcare professionals of reports of medication errors involving confusion between Reminyl and Amaryl (glimepiride). MedWatch Safety Info.
• Inactive Ingredient Database

October 25, 2004

• Drug Approval Reports
  • Biological Products Approved under Subpart E
  • CDER User Efficacy Supplements Approved in  Fiscal Year 2004
  • Efficacy Supplements Approved (Biologics) in Fiscal Year 2004
  • FY 2004 Priority Approvals
  • FY 2004 User Fee NME Drug and New Biologic Approvals
  • NDA and BLA Approvals for Calendar Year 2004
  • NDAs Approved under Subpart H

  • NDA Supplements Approved under Subpart H  

  • New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2004 
• New and Generic Drug Approvals
  • Carvedilol Tablet, Ranbaxy, Tentative Approval
  • Diruil (chlorothiazide) intravenous Injection and tablets, Merck & Co., Labeling Revision
  • Evoclin (clindamycin phosphate) Foam, Connetics Corp, Approval
  • InnoPran XL (propranolol hydrochloride) Extended Release Capsules, Reliant, Labeling Revision
  • Mirtazapine Tablets, Aurobindo Pharma, Approval
  • Sustiva (efavirenz) tablets, Bristol-Myers Squibb, Labeling Revision
  • Sustiva (efavirenz) capsules, Bristol-Myers Squibb, Labeling Revision
  • Tikosyn (dofetilide) Capsules, Pfizer Inc., Labeling Revision
  • Xenical (Orlistat) Capsules, Hoffman-LaRoche, Efficacy Supplement with Clinical Data to Support

October 22, 2004

• New and Generic Drug Approvals
  • Betimol (timolol ophthalmic solution), Santen, Labeling Revision
  • Carboplatin Injection, American Pharmaceutical, Approval
  • Concerta (methylphenidate HCL) Extended-Release Tablets, McNeil, New or Modified Indication
  • Gabapentin Tablets, Purepac Pharma, Approval
  • Habitrol (nicotine transdermal system), Novartis, Package Change
  • Levaquin (Levofloxacin) Oral Solution, J & J Pharmaceuticals, Approval
  • PROPECIA (finasteride) Tablets, Merck & Co., Labeling Revision
• Orange Book: Query
• Orange Book: Cumulative Supplement No 9
• Orange Book: Information and Data Files
• Orange Book: Monthly Additions and Deletions

October 21, 2004

• Drug Master Files (updated)
• New and Generic Drug Approvals
  • Enbrel (etanercept), Immunex Corp., Efficacy Supplement
  • Lovenox (enoxaparin sodium) Injection, Aventis, Manufacturing Change or Addition
  • Nutropin Depot Injectable suspension), Genentech, Labeling Revision

October 20, 2004

• New and Generic Drug Approvals
  • Allegra-D 24 Hour Extended-Release Tablets, Aventis Pharma, Approval
  • KALETRA (Lopinavir/Ritonavir) capsules, Global Pharma, Efficacy Supplement with Clinical Data to Support
  • KALETRA (Lopinavir/Ritonavir) oral solution, Global Pharma, Efficacy Supplement with Clinical Data to Support
  • Metolazone Tablets, Mylan Pharma, Chemistry New Strength
  • Torsemide Tablets, Pliva Pharma, Chemistry New Strength

October 19, 2004

• New and Generic Drug Approvals
  • Alocril (nedocromil sodium ophthalmic solution), Allergan, Package Change & Labeling Revision
  • Aricept (donepezil HCl) Oral Solution, Eisai Medical Research, Approval
  • Aricept (donepezil HCl) Orally Disintegrating Tablet, Eisai Medical Research, Approval
  • Cefazolin Injection, Hikma Farmaceutica, Approval
  • Cefuroxime Axetil Tablets, Teva Pharma, Approval
  • Gabapentin Capsules, Watson Labs, Tentative Approval
  • LUPRON (leuprolide acetate) Injection, TAP Pharma, Labeling Revision

October 18, 2004

• FDA/ISPE Forum on New PAT Guidance, November 16, 2004, Arlington, VA (international locations also available) Meeting Information
• Manual of Policies and Procedures (MaPP)  4601.3 Children in the Workplace
• New and Generic Drug Approvals
  • Altace (ramipril) Capsules, King Pharma, Labeling Revision
  • Carboplatin Injection, Bedford Labs, Approval
  • Fosinopril Sodium Tablets, Andrx Pharma, Approval
  • Fuzeon (enfuvirtide) Injection, Hoffmann-La Roche, Accelerated Approval
  • Levofloxacin Tablets, Mylan Pharma, Approval
  • Metformin Hydrochloride Extended-Release Tablets, Barr Labs, Approval
  • Saizen (somatropin [rDNA origin]) Injection, Serono, New or Modified Indication
  • Ultra-TechneKow DTE (Technetium Tc99m Generator), Mallinckrodt, Control Supplement
  • Visine-A Eye Drop, Pfizer, Labeling Revision
• Office of Generic Drugs -  Statement on Expedited Review of Generic Drug Products for the Prophylaxis and Treatment of Illness Caused by Various Strains of the Influenza Virus.

October 15, 2004

• FDA today issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior ("suicidality") in children and adolescents being treated with antidepressant medications.
  • Antidepressant Use in Children, Adolescents and Adults (updated)
  • Public Health Advisory: Suicidality in Children and Adolescents Being Treated With Antidepressant Medications  
  • Labeling Change Request Letter for Antidepressant Medications  
• Paragraph IV Patent Certifications (no changes from 10/1/2004)

October 14, 2004

• New and Generic Drug Approvals
  • Carboplatin Injection, Bedford Labs, Approval
  • Carboplatin Injection, Mayne Pharma, Approval
  • Carboplatin Injection, Pharmachemie, Approval
  • Carboplatin Injection, American Pharmaceutical Partners, Approval
  • Finasteride Tablets, Dr. Reddy’s Labs, Tentative Approval
  • Metformin Hydrochloride Extended-Release Tablets, Eon Labs, Tentative Approval
  • Sandostatin LAR Depot (octreotide acetate) Injection, Novartis Pharma, Labeling Revision
  • Septocaine (articaine HCl 4% w/epinephrine 1:100,000) Injection, Deproco, Inc., Labeling Revision
• FDA approves four first-time generics for Carboplatin for initial and secondary treatment of advanced ovarian cancer. The reference listed drug is Paraplatin.

October 13, 2004

• Cyber Warning Letters for June and September, 2004

• FDA and Centocor notify healthcare professionals of revisions to the prescribing information for Remicade, indicated for the treatment of rheumatoid arthritis and Crohn's disease. In controlled studies of all TNFα-blocking agents, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients. MedWatch Safety Info.

• New and Generic Drug Approvals
  • Imitrex (sumatriptan) nasal spray, GlaxoSmithKline, Patient Population Altered
  • Norditropin Cartridges (somatropin rDNA origin) Injection, Novo Nordisk, New or Modified Indication
  • Plavix (clopidogrel bisulfate) Tablets, Sanofi-Synthelabo, Labeling Revision

October 12, 2004

• New and Generic Drug Approvals
  • Betamethasone Dipropionate Ointment, Taro Pharma, Approval
  • Fenoldopam Mesylate Injection, Bedford Labs, Approval
  • Flumazenil Injection, American Pharma, Approval
  • Flumazenil Injection, Baxter HealthCare, Approval
  • Flumazenil Injection, Bedford Labs, Approval
  • Flumazenil Injection, Apotex Corp., Approval
  • Flumazenil Injection, Sicor Pharma, Approval
  • Fosinopril Sodium Tablets, Sandoz Inc., Approval
  • Hydrocodone Bitartrate and Ibuprofen Tablets, Interpharm, Supplement
  • NovoLog (insulin aspart [rDNA origin] injection), Novo Nordisk, Labeling Revision
  • NovoLog Mix 70/30, Novo Nordisk, Labeling Revision
  • VANTAS (histrelin implant), Valera Pharma, Approval

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