UpDate : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 07:57:16 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: October 16, 2008 |
The following new items were added to the CDRH web pages on October 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |  |  |
| Summary Information for: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) - In-Stent Restenosis (ISR) Indication | |
UpDate : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 09:16:10 -0500 (CDT)
Subject: CDER New October 10-15
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October 15, 2008
- Drugs@FDA Downloadable Data Files (updated)
- New pages for Rheumatology Therapeutics.
October 14, 2008
- CDER Organization Charts [HTML] [PDF] (updated)
- New and Generic Drug Approvals
- AmBisome (amphotericin B) Liposome Injection, Astellas Pharma US, Inc., Labeling Revision
- Cetirizine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
- Dantrium (dantrolene sodium) Injection, JHP Pharmaceuticals, Labeling Revision
- Fosamax (alendronate sodium) Oral Solution, Merck & Co., Inc., Packaging Addition
- Fosamax (alendronate sodium) Tablets, Merck & Co., Inc., Packaging Addition
- Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets, Merck & Co., Inc., Packaging Addition
- Letairis (ambrisentan) Tablets, Gilead Sciences, Inc., Labeling Revision
- Prinivil (lisinopril) Tablets, Merck Research Laboratories, Labeling Revision
- Prinzide (lisinopril and hydrochlorothiazide) Tablets, Merck Research Laboratories, Labeling Revision
- Prismasol Solutions Gambro Lundia AB, Formulation Revision
- Rapflo (silodosin) Capsules, Watson Laboratories, Inc., Approval
- Risperdal Consta (risperidone) Intramuscular Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
- Risperidone Tablets, Aurobindo Pharma Ltd., Approval
- Risperidone Tablets, Wockhardt Ltd., Approval
- Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
- Vaprisol (conivaptan hydrochloride) I.V. Injection, Astellas Pharma US, Inc., Formulation Revision
October 10, 2008
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
- International Conference on Harmonization (ICH) Public Meeting, October 21, 2008, Rockville, Maryland: Meeting information and registration - (updated)
- Podcast Transcript - Measures Undertaken to Address Concerns about Marketing of Unapproved Drugs
UpDate : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:14:08 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Public Workshop: Adjuvants and Adjuvanted Preventative and Therapeutic Vaccines for Infectious Disease Indications
Posted: 10/16/2008; Meeting Dates: 12/2-3/2008
UpDate : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:28:45 -0500 (CDT)
Subject: Improper Use of Decorative Contacts May Haunt You
Improper Use of Decorative Contacts May Haunt You
Thu, 16 Oct 2008 09:05:00 -0500
Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision
UpDate : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 14:11:50 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Substantially Equivalent 510(k) Device - AMICUS® Separator: Software 3.1 with EDI Export - Fenwal Inc.
Posted:10/16/2008, Clearance Date: 10/2/2008
UpDate : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:28:44 -0500 (CDT)
Subject: Use Caution With Ayurvedic Products
Use Caution With Ayurvedic Products
Thu, 16 Oct 2008 09:05:00 -0500
The presence of heavy metals in some Ayurvedic products makes them potentially harmful.
UpDate : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 10:34:11 -0500 (CDT)
Subject: FDA MedWatch- Dextroamphetamine Sulfate 5mg Tablets- Drug Recall Due To The Potential For Oversized Tablets
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Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Dextroamphetamine
UpDate : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 16 Oct 2008 16:03:35 -0500 (CDT)
Subject: FDA Approves Updated Labeling for Psoriasis Drug Raptiva
FDA Approves Updated Labeling for Psoriasis Drug Raptiva
Thu, 16 Oct 2008 15:33:00 -0500
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.
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