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

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 06:06:38 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: May 30, 2008

The following new items were added to the CDRH web pages on May 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
	Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System
	Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
	Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
	Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:10:47 -0500 (CDT)
Subject: FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
Fri, 30 May 2008 11:00:00 -0500

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 30 May 2008 11:24:03 -0500 (CDT)
Subject: FDA MedWatch-Viril-ity Power (VIP) Tablets: Recall Of Supplement Product Because It Contains A Potentially Harmful Undeclared Ingredient

International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs ( such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.

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#VIP

 

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