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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 make sure you are seeing the latest version. 

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November 17, 2004

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

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

November 9, 2004

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

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

November 2, 2004

November 1, 2004

October 29, 2004

October 28, 2004

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

October 22, 2004

October 21, 2004

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

October 15, 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


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