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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