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                  CDER News Archive
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November 1, 2004

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: solved; 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 [] or [] 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

    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

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