Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book

BPCA/Pediatric Exclusivity Statistics:

• BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated)
• Written Requests Issued (updated)
• Written Requests Statistics (updated)

New and Generic Drug Approvals

• Advil (ibuprofen) Tablets, Wyeth Consumer
  Healthcare, Labeling Revision
• DOXIL (doxorubicin hydrochloride) Injection, Alza Corp., Accelerated Approval
• Hydroxyzine Hydrochloride Tablets, Sun Pharmaceutical Industries, Inc., Approval
• Torsemide Injection, Bedford Laboratories, Approval
• Zocor (simvastatin) Tablets, Merck & Co., Inc., Labeling Revision

Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

June 12, 2008

Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)

Drugs@FDA Downloadable Data Files (updated)

FDA releases its third issue of the FDA Drug Safety Newsletter.

New and Generic Drug Approvals

• Almotriptan Malate Tablets, Teva Pharmaceuticals USA, Tentative Approval
• Amoxil (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
• Amoxil (amoxicillin) Tablets, GlaxoSmithKline, Labeling Revision
• Amoxil (amoxicillin) Oral Suspension, GlaxoSmithKline, Labeling Revision
• Amoxil (amoxicillin) Chewable Tablets, GlaxoSmithKline, Labeling Revision
• AUGMENTIN 250 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
• AUGMENTIN 500 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
• AUGMENTIN 875 (amoxicillin and clavulanate potassium) Tablets, GlaxoSmithKline, Labeling Revision
• Ciclopirox Gel, Nycomed US, Inc., Approval
• Levo-T (levothyroxine sodium) Tablets, Alara Pharmaceutical Corp., Labeling Revision
• Prednisolone Sodium Phosphate Oral Solution, Pharmaceutical Associates, Inc., Approval
• Ramipril Capsules, Lupin Pharmaceuticals, Inc., Approval
• Valsartan Tablets, IVAX Pharmaceuticals, Inc., Tentative Approval 

Statistical Review and Evaluation: Antiepileptic Drugs and Suicidality 

June 11, 2008

ETHEX Corporation voluntarily recalls a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. MedWatch Safety Information

Guidance for Industry: Providing Regulatory Submissions in Electronic Format –Postmarketing Individual Case Safety Reports [PDF]

• Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/
  regulatory/ersr/#Postmarketing

Guidance for Industry: Revision: Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications [PDF].

• To ensure you have the most recent versions of the specifications referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http://www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://www.fda.gov/cder/regulatory
  /ersr/ectd.htm.

Paragraph IV Patent Certifications (updated)

June 10, 2008

Manual of Policies and Procedures (MaPP) 4657.1R Alternate Work Schedules (AWS)

Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF]

New and Generic Drug Approvals

Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Efficacy Supplement with Clinical Data to Support

Flector (diclofenac epolamine) Patch, Institute Biochimique SA (IBSA), Labeling Revision

Naloxone Hydrochloride Injection, International Medication Systems, Ltd., Facility Addition

Optison (albumin human) Injection, GE Healthcare, Labeling Revision

Zaleplon Capsules, Roxane Laboratories, Inc., Approval

Zaleplon Capsules, Genpharm ULC, Approval

Zaleplon Capsules, Sandoz, Inc., Approval

Zaleplon Capsules, Upsher-Smith Laboratories, Inc., Approval

Zaleplon Capsules, Aurobindo Pharma USA, Inc., Approval

Zaleplon Capsules, Unichem Pharmaceuticals USA, Inc., Approval

Zaleplon Capsules, Teva Pharmaceuticals USA, Approval

Zetia (ezetimibe) Tablets, MSP Singapore Co., LLC, Labeling Revision

Zetia (ezetimibe) Tablets, MSP Singapore Co., LLC, Patient Population Altered

CDER Drug Links

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June 13, 2008 Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, June 12, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule). Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule). Consumer Information on: Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads - P070008   June 11, 2008 Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary   June 10, 2008 Consumer Information on: ELA Ovatio CRT-D System - P060027 Consumer Information on: Talent Thoracic Stent Graft System - P070007   June 9, 2008 Medical Device Safety, Tips & Articles: How Human Factors Lead to Medical Device Adverse Events Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Summary Information for: Talent Thoracic Stent Graft System

Medical Device Links

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