From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 05:48:12 -0500 (CDT)
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: June 30, 2008 |
The following new items were added to the CDRH web pages on June 27, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies. |  |  |
| Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations. | | |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 08:03:28 -0500 (CDT)
Subject: Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27)
Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27)
Mon, 30 Jun 2008 07:35:00 -0500
The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 08:04:33 -0500 (CDT)
Subject: Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Mon, 30 Jun 2008 07:35:00 -0500
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products.
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 16:04:22 -0500 (CDT)
Subject: Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
Mon, 30 Jun 2008 15:32:00 -0500
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 16:20:48 -0500 (CDT)
Subject: CDER New 6/30/2008
| ||||||||||||
June 30, 2008
- New and Generic Drug Approvals
- Adenosine Injection, Bedford Laboratories, Tentative Approval
- Allegra (fexofenadine hydrochloride) Oral Suspension, Sanofi-Aventis US, LLC, Labeling Revision
- Allegra (fexofenadine hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
- Anastrozole (anastrozone) Tablets, Sandoz, Inc., Tentative Approval
- Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
- Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Labeling Revision
- Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Patient Population Altered
- Famotidine Preservative-Free (famotidine) Injection, Akorn-Strides, LLC, Approval
- Forteo (teriparatide [rDNA origin]) Subcutaneous Injection, Eli Lilly and Co., Control Supplement
- Granisetron Hydrochloride Injection, Bedford Laboratories, Approval
- Lamotrigine Tablets, Cobalt Laboratories, Inc., Tentative Approval
- Linezolid Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
- Metvixia (methyl aminolevulinate hydrochloride) Cream, Photocure, ASA, Efficacy Supplement with Clinical Data to Support
- Sarafem (fluoxetine hydrochloride) Capsules, Eli Lilly and Co., Labeling Revision
- Xyzal (levocetirizine dihydrochloride) Oral Solution, UCB, Inc., Labeling Revision
- Zidovudine Syrup, Cipla, Ltd., Approval
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 14:04:28 -0500 (CDT)
Subject: FDA MedWatch- CellCept (mycophenolate mofetil)-Reports Of Progressive Multifocal Leukoencephalopathy In Patients Treated With CellCept
  |
Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept.
Read the entire 2008 MedWatch Safety Summary, including the manufacturer's Dear Healthcare Professional Letter regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 30 Jun 2008 16:32:15 -0500 (CDT)
Subject: MedWatch - 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination
| |
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
Read the complete MedWatch 2008 Safety Summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chlorhexidine
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
