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, 29 Feb 2008 06:06:15 -0600 (CST)
Subject: CDRH New Update

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

Date: February 29, 2008

The following new items were added to the CDRH web pages on February 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Feb 2008 14:05:24 -0600 (CST)
Subject: Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements (Feb. 28)

Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements (Feb. 28)
Fri, 29 Feb 2008 12:33:00 -0600

Palo Alto Labs is conducting a voluntary nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED).

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 29 Feb 2008 07:42:25 -0600 (CST)
Subject: FDA MedWatch- Spiriva (tiotropium bromide inhalation powder) & Foradil (formoterol fumarate inhalation powder) Capsules- Correct Use Of The Products

FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the National Poison Control Center have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA's Public Health Advisory regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Spiriva

 

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