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Center for Drug Evaluation &
Research (CDER) News

• CDER Organization Charts [HTML] [PDF] (updated)

November 6, 2008

• Drugs Shortages: Current Drug Shortages; Argatroban Injection
• PDA/FDA Pharmaceutical Ingredient Supply Chain Conference, December 3-5, 2008, Coronado, California: Meeting information and registration
• New and Generic Drug Approvals
  • Adenosine Injection, Akorn Inc., Approval
  • Evamist (estradiol) Transdermal Spray, KV Pharmaceutical Co., Packaging Addition
  • Irinotecan Hydrochloride Injection, 'Pliva-Lachema, AS, Approval
  • Myambutol (ethambutol hydrochloride) Tablets, Stat-Trade Inc., Package Change
  • Norditropin (somatropin [rDNA origin]) Injection, Novo Nordisk, Inc., New or Modified Indication
  • Pamidronate Disodium Injection, Akorn-Strides, LLC, Approval
  • Paxil (paroxetine hydrochloride) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • Paxil (paroxetine hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets, GlaxoSmithKline, Labeling Revision
  • Requip XL (ropinirole hydrochloride) Extended-Release Tablets, GlaxoSmithKline, Formulation Revision
  • Sertraline Hydrochloride Oral Concentrate, Aurobindo Pharma Ltd., Approval
  • Skelaxin (metaxalone)  Tablets, King Pharmaceuticals Research and Development, Inc., Labeling Revision
  • Theophylline in Dextrose 5% in Plastic Container Injection, Hospira, Inc., Labeling Revision
  • Toviaz (fesoterodine fumarate) Tablets, Pfizer Inc., Approval

November 5, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Amiodarone Hydrochloride Injection, Wockhardt, Ltd., Approval
  • Glynase (glyburide) Tablets, Pharmacia & Upjohn Co., Labeling Revision
  • Haloperidol (haloperidol lactate) Injection, APP Pharmaceuticals, LLC, Labeling
  • Haloperidol Decanoate Injection, APP Pharmaceuticals, LLC, Labeling
  • Ortho Evra (norelgestromin and ethinyl estradiol) Patch, 'Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Risperidone Tablets, Torrent Pharmaceuticals Limited, Approval
  • Vesicare (solifenacin succinate) Tablets, Astellas Pharma US, Inc, Labeling Revision
• Office of Generic Drugs: September and October First-Time Generic Drug Approvals
• Pediatric Research Equity Act (PREA) Labeling Changes (updated)

November 3, 2008

• Drug Approval Reports
  • Efficacy Supplement Approvals
  • NDA and BLA Approvals
  • NME Drug and New Biologic Approvals
  • Priority NDA and BLA Approvals
• National Drug Code Directory
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  • Search
• New and Generic Drug Approvals
  • Carbidopa and Levodopa Tablets, Sun Pharmaceutical Industries Ltd., Approval
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Apotex Corp., Approval
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Hi-Tech Pharmacal Co., Inc., Approval
  • Factive (gemifloxacin mesylate) Tablets, Oscient Pharmaceuticals Corp., Package Change
  • Monistat 3 Combination Pack (miconazole nitrate) Vaginal Cream, Johnson & Johnson Consumer & Personal Products Worldwide, Manufacturing Change or Addition
  • Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals North America, Inc., Patient Population Altered
  • Prevacid (lansoprazole) Delayed-Release Oral Suspension, Takeda Pharmaceuticals North America, Inc., Labeling Revision
  • Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals North America, Inc., Labeling Revision
  • Tenoretic (atenolol and chlorthalidone) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
  • Vimpat (lacosamide) Tablets, Schwarz Biosciences, Inc., Approval
  • Vimpat (lacosamide) Injection, Schwarz Biosciences, Inc., Approval
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Paragraph IV Patent Certifications (updated)
• Postmarketing Study Commitments (updated)

CDER Drug Links

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• Contact the Center for Drug Evaluation and Research

• CDER Presentations

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November 7, 2008
	Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
November 6, 2008
	510(k) Final Decisions - October 2008
	Hematology and Pathology Devices Panel Advisory Meeting, July 18, 2008 - Minutes
	Class I Medical Device Recall: Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge
November 3, 2008
	Immunology Devices Panel Advisory Meeting, December 3, 2008 - Notice of Meeting

Medical Device Links

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