Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 03:39:21 -0500 (CDT)
Subject: CDER New 4/23 - 25/2008
| ||||||||||||
April 25, 2008
- FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation
- FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products
- New and Generic Drug Approvals
- Dipyridamole Tablets, Lannett, Approval
- Epoprostenol Sodium Injection, Teva Parenteral, Approval
- Ondansetron Injection, Akorn-Strides, Approval
- Paragraph IV Patent Certifications (updated)
- Postmarketing Study Commitments: Introduction (updated)
April 24, 2008
- New and Generic Drug Approvals
- Actonel (risedronate sodium) Tablets, Procter & Gamble, Labeling Revision
- Actonel (risedronate sodium) Tablets, Procter & Gamble, New Dosage Regimen
- Declomycin (demeclocycline hydrochloride) Tablets, Stiefel Labs, Labeling Revision
- Vyvanse (lisdexamfetamine dimesylate) Capsule, New River Pharmacueticals, Patient Population Altered
- Office of Nonprescription Products: Rx to OTC Switch (updated)
April 23, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New and Generic Drug Approvals
- Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Biovail Labs, Approval
- Cabergoline Tablets, Cobalt Labs, Approval
- Children's Cetirizine Hydrochloride Allergy Syrup, Taro Pharma, Approval
- Children's Cetirizine Hydrochloride Hives Relief Syrup, Taro Pharma, Approval
- Irinotecan Hydrochloride Injection, Sun Pharma, Approval
- Prevacid (lansoprazole) Delayed-Release Oral Suspension, TAP Pharma, Labeling Revision
- Prevacid (lansoprazole) Delayed-Release Capsules, TAP Pharma, Labeling Revision
- Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, TAP Pharma, Labeling Revision
- Topiramate Tablets, Apotex, Tentative Approval
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 06:21:27 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: April 28, 2008 |
The following new items were added to the CDRH web pages on April 25, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Clears Glove Made from New Type of Latex |  |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:08:00 -0500 (CDT)
Subject: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as precaution (April 25)
Mon, 28 Apr 2008 09:50:00 -0500
Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 10:19:25 -0500 (CDT)
Subject: Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)
Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)
Mon, 28 Apr 2008 09:50:00 -0500
Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 13:07:50 -0500 (CDT)
Subject: Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue)
| ||||||||||||
Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue)
Mon, 28 Apr 2008 13:25:00 -0500
Covidien now has Lymphazurin 1% injection available.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 28 Apr 2008 14:44:16 -0500 (CDT)
Subject: FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
  |
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
