• FDA issues a Public Health Advisory and Information for Healthcare Professional sheet for Chantix (varenicline).
• Guidance Documents
  • Comprehensive List of Guidance Documents
  • New/Revised/Withdrawn List for 2008
  • New/Revised/Withdrawn List for 2007
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

January 31, 2008

• FDA issues an FDA Alert and Information for Healthcare Professional sheet for suicidality and antiepileptic drugs.
• New and Generic Drug Approvals
  • Brimonidine Tartrate Ophthalmic Solution, Sandoz Inc., Approval
  • Calcium Acetate Tablets USP, Roxane Labs, Approval
  • Effexor XR (venlafaxine HCl) Extended Release Capsules, Wyeth Pharma, Labeling Revision
  • Effexor (venlafaxine HCl) Tablet, , Wyeth Pharma, Labeling Revision
  • Granisetron Hydrochloride Tablets, Mylan Pharma, Approval
  • Inspra (eplerenone) Tablets, Pfizer, Patient Population Altered
  • Phenytoin Sodium Extended Capsules, Wockhardt Inc., Approval
  • Sumatriptan Succinate Tablets, Aurobindo Pharma, Tentative Approval

January 30, 2008

• 2nd Annual FDA/DIA Statistics Forum, Marriott Bethesda, Bethesda, MD, April 13-16, 2008 Meeting Information.
• Approved Drug Products with Therapeutic Equivalence Evaluations 28th Edition
  • Preface
  • Annual Edition (10 MB)
• CDER User Fees: The FY 2007 Cleanup Product and Establishment Fee Invoices were mailed Monday, January 28, 2008. Payments are due within 30 days of the date of the invoice.  Please note that the CDER User Fee Staff is scheduled to move on or around February 8, 2008.
• Dissolution Methods Database (updated)
• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Calcitriol Injection, Akorn Inc., Approval
  • Dextroamphetamine Sulfate Oral Solution, Mikart Inc., Approval
  • Lamivudine Tablets, InvaGen Pharma, Tentative Approval
  • Lunesta (eszopiclone)  Tablets, Sepracor Inc., Labeling Revision
  • Tamsulosin Hydrochloride Capsules, Teva Pharma, Tentative Approval
  • Technetium TC-99M Mebrofenin Injection, CIS Inc., Approval 
• Orange Book FR Safety or Effectiveness Determinations List (updated)
• Paragraph IV Patent Certifications (updated)
• Postmarketing Study Commitments (updated)

January 29, 2008

• Drug Master Files (updated)
• New and Generic Drug Approvals
  • Bleomycin Injection, Abraxis Pharma, Approval
  • Dipyridamole Tablets, Zydus Pharma, Approval
  • Phendimetrazine Tartrate Tablets, Actavis Totowa, Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharma, Labeling Revision
  • Xyzal (levocetirizine dihydrochloride) Oral Solution, UCB Inc., Approval

January 28, 2008

• New and Generic Drug Approvals
  • Butalbital, Acetaminophen, Caffeine w/Codeine Phosphate Capsules, West-ward Pharma, Supplier Addition
  • Co-Gesic  (Hydrocodone Bitartrate and Acetaminophen) Tablets, Schwarz Pharma, Control Suppl.
  • Emend (fosaprepitant dimeglumine) Injection, Merck & Co., Approval
  • EstroGel (estradiol) Gel, Ascend Therapeutics, Labeling Revision
  • LOTRISONE (clotrimazole and betamethasone dipropionate) Cream, Schering-Plough, Labeling Revision
  • LOTRISONE (clotrimazole and betamethasone dipropionate) Lotion, Schering-Plough, Labeling Revision
  • Methadone Hydrochloride Tablets, Mallinckrodt, Control Suppl.
  • Oxycodone and Acetaminophen Tablets, Mallinckrodt, Control Suppl.

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January 31, 2008
	Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices;
	Obstetrics and Gynecology Devices Panel Advisory Meeting, December 13-14, 2007 - Transcripts
January 30, 2008
	Class I Medical Device Recall: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes)
January 29, 2008
	Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
January 28, 2008
	Information on Wrinkle Fillers

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