Wednesday, July 2, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 11:34:55 -0500 (CDT)
Subject: The July 2008 FDA Patient Safety News is now available...

FDA Patient Safety News - www.fda.gov/psn

You can find more information about FDA Patient Safety News, and watch or download the video program on our web site (http://www.fda.gov/psn). Stories in the July 2008 edition include:

New Skin Graft Adhesive Approved
The fibrin sealant Artiss has a lower thrombin concentration than other sealants, giving surgeons more time to position the skin graft over a burn…

New Non-Refrigerated Coagulation Product
A new formulation allows NovoSeven RT to be stored at room temperature for up to two years, giving greater flexibility in managing blood disorders…

Update on Potentially Contaminated Heparin
Healthcare professionals should report adverse reactions involving drugs or devices that contain heparin and ensure that recalled products have been removed…

FDA Takes Action on Injectable Colchicine
Colchicine for injection is not approved and is especially hazardous because the margin between an effective dose and a toxic dose is very narrow…

FDA Studying Heart Attack Risk with Ziagen, Videx

FDA's evaluation prompted by data from international study of HIV patients…

Preventing Fatal Overdoses with Cerebyx (fosphenytoin)
The Institute for Safe Medication Practices warns about dosing errors that led to pediatric deaths…

Albuterol Inhalers: Making the Switch
People with asthma, emphysema and other airway diseases need to switch to inhalers that don't use CFCs…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov

Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 12:26:35 -0500 (CDT)
Subject: CDER New 6/26 & 27/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

June 27, 2008

June 26, 2008

  • New and Generic Drug Approvals
    • Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision
    • Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc., New or Modified Indication
    • Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
    • Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc., Approval
    • Azithromycin Oral Suspension, Teva Pharmaceuticals USA, Approval
    • Celestone Soluspan (betamethasone acetate and betamethasone sodium phosphate) Injection, Schering Corp., Labeling Revision
    • Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics, Inc., Approval
    • Famotidine Injection, Akorn-Strides, LLC, Approval
    • PrandiMet (repaglinide and metformin hydrochloride) Tablets, Novo Nordisk, Inc., Approval
    • Viramune (nevirapine) Oral Suspension, Boehringer Ingelheim Pharmaceuticals, Inc., Patient Population Altered
    • Viramune (nevirapine) Tablet, Boehringer Ingelheim Pharmaceuticals, Inc., Patient Population Altered

Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 15:51:00 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update July 2008

* * * Interstate Certified Shellfish Shippers List * * *

The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.

July 2008 Update

Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 17:02:24 -0500 (CDT)
Subject: CDER New 7/1/2008

FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
CDERnew Logo

July 1, 2008

Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 11:17:34 -0500 (CDT)
Subject: FDA MedWatch - March 2008 Safety-Related Labeling Changes Posted

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The March 2008 posting includes 50 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/mar08_quickview.htm

The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/mar08.htm

In March 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Aranesp (darbepoetin alfa) for Injection

Epogen (epoetin alfa) for Injection

Avodart (dutasteride) Soft Gelatin Capsules

Reyataz (atazanavir sulfate) Capsuleseyataz (atazanavir sulfate) Capsules

Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension

Vfend I.V. (voriconazole) for Injection, Vfend Tablets (voriconazole), Vfend (voriconazole) for Oral Suspension

Aczone (dapsone) Gel, 5%

Advair HFA (fluticasone propionate and salmeterol ) Inhalation Aerosol

Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension)

Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets

Augmentin (amoxicillin/clavulanate potassium) Tablets

Depakote ER (divalproex sodium) Extended Release Tablets

Depakote (divalproex sodium) Sprinkle Capsules

Invanz (ertapenem for injection)

Merrem I.V. (meropenem for injection) for Intravenous Use

Monurol (fosfomycin tromethamine) Sachet

NovoLog (insulin aspart [rDNA origin] injection) Solution for Subcutaneous Use

Penicillin G Potassium Injection, USP

Premarin Intravenous (conjugated estrogens, USP) for Injection

Premarin (conjugated estrogens tablets, USP)

Premarin (conjugated estrogens) Vaginal Cream in a nonliquefying base

Prempro (conjugated estrogens/medroxyprogesterone acetate tablets)/Premphase (conjugated estrogens/medroxyprogesterone acetate tablets)

Prezista (darunavir) Tablets

Primaxin I.M. (imipenem and cilastatin for injectable suspension)

Primaxin I.V. (imipenem and cilastatin for injection)

Sandostatin LAR Depot (octreotide acetate for injectable suspension)

Serevent Diskus (salmeterol xinafoate inhalation powder)

Zevalin (ibritumomab tiuxetan) Injection for Intravenous Use

Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 11:50:14 -0500 (CDT)
Subject: FDA MedWatch - April 2008 drug safety-related labeling changes for 47 drugs now available on web

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

The April 2008 posting includes 47 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.

The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/apr08_quickview.htm

The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/apr08.htm

In April 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:

Aldurazyme (laronidase) Solution for Intravenous Infusion Only

Emtriva (emtricitabine) Capsules and Oral Solution

Lotronex (alosetron hydrochloride) Tablets

Advair Diskus (fluticasone propionate and salmeterol inhalation powder)

Amitiza (lubiprostone) Capsules

Crixivan (indinavir sulfate) Capsules

Tigan (trimethobenzamide hydrochloride) Injectable for Intramuscular Use Only

Actonel (risedronate sodium) Tablets

Augmentin (amoxicillin/clavulanate potassium) Tablets

Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension

Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets

Declomycin (demeclocycline hydrochloride) Tablets

Evamist (estradiol transdermal spray)

Levaquin (levofloxacin) Tablets and Oral Solution, Levaquin (levofloxacin) Injection, for Intravenous Use

Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use

Luvox (fluvoxamine maleate) Tablets

Nafcillin Injection, USP in PL 2040 Plastic Container For Intravenous Use Only (Galaxy Container)

Neulasta (pegfilgrastim)

Orencia (abatacept) Lyophilized Powder for Intravenous Infusion

Oxacillin (oxacillin) Injection, Solution in Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040)

Pipracil (piperacillin for injection) for Intravenous and Intramuscular Use

Prevacid (lansoprazole) Delayed-Release Capsules and Oral Suspension, Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

Timentin (ticarcillin disodium and clavulanate potassium) for Intravenous Administration

Timentin (ticarcillin disodium and clavulanate potassium) Injection - Galaxy (PL 2040) Plastic Container

Unasyn (ampicillin sodium/sulbactam sodium)

Vyvanse (lisdexamfetamine dimesylate) Capsules

Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)

Zosyn (piperacillin and tazobactam for injection) Individual Vials and Zosyn (piperacillin and tazobactam for injection) Pharmacy Bulk Package

Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 1 Jul 2008 13:26:47 -0500 (CDT)
Subject: FDA MedWatch - The July 2008 FDA Patient Safety News Is Now Available

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the July 2008 edition include:

New Skin Graft Adhesive Approved
The fibrin sealant Artiss has a lower thrombin concentration than other sealants, giving surgeons more time to position the skin graft over a burn…

New Non-Refrigerated Coagulation Product
A new formulation allows NovoSeven RT to be stored at room temperature for up to two years, giving greater flexibility in managing blood disorders…

Update on Potentially Contaminated Heparin
Healthcare professionals should report adverse reactions involving drugs or devices that contain heparin and ensure that recalled products have been removed…

FDA Takes Action on Injectable Colchicine
Colchicine for injection is not approved and is especially hazardous because the margin between an effective dose and a toxic dose is very narrow…

FDA Studying Heart Attack Risk with Ziagen, Videx

FDA's evaluation prompted by data from international study of HIV patients…

Preventing Fatal Overdoses with Cerebyx (fosphenytoin)
The Institute for Safe Medication Practices warns about dosing errors that led to pediatric deaths…

Albuterol Inhalers: Making the Switch
People with asthma, emphysema and other airway diseases need to switch to inhalers that don't use CFCs…

For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

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