FDA News Digest

FDA News Digest

June 30, 2008

_____________________________________

IN THIS WEEK'S ISSUE

» News

-- FDA Approves First Generic Risperidone to Treat Psychiatric Conditions

» Congressional Testimony

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

__________________________________________

NEWS

FDA Approves First Generic Risperidone to Treat Psychiatric Conditions

FDA has approved the first generic versions of Risperdal (risperidone), an antipsychotic drug used to treat schizophrenia, bipolar disorder, and other psychiatric conditions. The labeling of generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01855.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

_____________________________________________

CONGRESSIONAL TESTIMONY

June 24 -- FDA Assistant Commissioner for Science Linda Tollefson, D.V.M., appeared before the Senate Committee on Health, Education, Labor and Pensions.

Subject: antimicrobial resistance in the United States

http://www.fda.gov/ola/2008/antimicrobials062408.html

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

__________________________________________________________

SAFETY ALERTS/RECALLS

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

____________________________________________________________________

UPCOMING PUBLIC MEETINGS

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

Consumer updates in the spotlight this week are:

› Stay Healthy While Traveling Abroad

http://www.fda.gov/consumer/updates/travel_health062308.html

› Beware of Bug Bites and Stings

http://www.fda.gov/consumer/updates/bugbites061908.html

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

Thanks for subscribing to FDA News Digest.

Our next issue will be sent July 7.

---

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

Update : 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 08:12:10 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 27, 2008

The following new items were added to the CDRH web pages on June 26, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Brief Summary
	Federal Register: Hematology and Pathology Devices Panel fo the Medical Devices Advisory Committee; Notice of Meeting.

---

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 09:03:27 -0500 (CDT)
Subject: CDER's Small Business Assistance Bulletin

Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via e-mail.

1. A FDA/Consumer Healthcare Products Association Workshop: Current Good Manufacturing Practices (CGMP) will be held on August 4, 2008, in Chicago, Illinois http://www.chpa-info.org/NR/rdonlyres/2E848024-6B23-4AFD-AD42-CC047A700ACB/0/2008_SummerWorkshopReg3.pdf

2. The Office of Compliance has an updated website for contacts: http://www.fda.gov/cder/Offices/Compliance/default.htm#whatwedo

3. An updated organizational chart for CDER is available at this website: http://www.fda.gov/cder/cderorg/cder-all.pdf

4. The Food and Drug Administration in a Federal Register notice of June 19, 2008, proposed that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is issuing this proposed rule because the agency did not receive any data and information on these ingredients in response to the request on December 31, 2003 (68 FR 75585). This proposed rule is part of FDA's ongoing review of OTC drug products. http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-13826.pdf

5. An FDA organizational chart which lists the Centers/Offices including the Office of the Commissioner is available at this website: http://www.fda.gov/opacom/7org.html

6. HHS Secretary Mike Leavitt announced on June 12. 2008, that the Centers for Disease Control and Prevention (CDC) has awarded $12.9 million for the development of low-cost influenza tests that can detect and differentiate seasonal human influenza viruses from avian influenza within three hours. http://www.hhs.gov/news/press/2008pres/06/20080612a.html

7. The 10th Annual National Institutes of Health Small Business Innovation Research Conference will be held July 22-23 in Atlanta, GA. http://grants.nih.gov/grants/funding/sbirconf2008/index.htm

8. The National Institutes of Health has a New Investigators Program. Information is available at this website: http://grants.nih.gov/grants/new_investigators/index.htm

Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov

---

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 27 Jun 2008 16:09:52 -0500 (CDT)
Subject: FDA Data Standards Update - Terminology Update - UNIIs

Greetings,

The FDA Data Standards Council's website was updated Friday, June 27, 2008, to include an update to the list of Unique Ingredient Identifiers (UNIIs).

Hyperlinks to the updated list of UNIIs can be found on either of these web pages:

Substance Registration System - Unique Ingredient Identifier: http://www.fda.gov/oc/datacouncil/SRS.htm

Structured Product Labeling Resources: http://www.fda.gov/oc/datacouncil/spl.html

Lonnie Smith

Project Manager

Food and Drug Administration

---

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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

Update : 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 26 Jun 2008 07:02:42 -0500 (CDT)
Subject: Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)

Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Thu, 26 Jun 2008 06:08:00 -0500

Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected.

---

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 26 Jun 2008 07:07:06 -0500 (CDT)
Subject: Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24)

Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24)
Thu, 26 Jun 2008 07:05:00 -0500

The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund.

---

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 26 Jun 2008 07:45:30 -0500 (CDT)
Subject: CDER New 6/25/2008

June 25, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision
  • KALETRA (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Patient Population Altered
  • KALETRA (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
  • Spiriva Inhalation Powder, Boehringer Ingelheim, Labeling Revision

---

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 26 Jun 2008 16:03:11 -0500 (CDT)
Subject: FDA 101: Biological Products

FDA 101: Biological Products
Thu, 26 Jun 2008 15:46:00 -0500

Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies.

---

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 26 Jun 2008 16:03:27 -0500 (CDT)
Subject: Wrinkle Relief: Injectable Cosmetic Fillers

Wrinkle Relief: Injectable Cosmetic Fillers
Thu, 26 Jun 2008 15:46:00 -0500

Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done.

---

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420