FDA News Digest
June
27,
2005
__________________________________________________
IN
THIS WEEK'S ISSUE
-- FDA Grants Tentative Approval of
Generic Drug for AIDS Relief
-- Aptivus (tipranavir) Approved for HIV
Patients with Advanced Disease
-- Heart Failure Drug BiDil Approved for
Black Patients
-- Generic AIDS Drug Efavirenz Gets Tentative
Approval
-- Food Safety Tips for a Safe and Healthy 4th of
July
-- FDA/USDA Safety Measures Kept BSE-Positive Cow Out of Food
Supply
-- Acting Commissioner Crawford, Singapore's Tan Sign
MOU
-- Recalls/Safety Alerts
-- Public Meetings
--
Question of the
Week
__________________________________________________
FDA
Grants Tentative Approval of Generic Drug for AIDS Relief
As
part of the President's Emergency Plan for AIDS Relief, FDA has granted
tentative approval of generic Viramune tablets made by Aurobindo Pharma and
Ranbaxy Laboratories for the treatment of HIV/AIDS. The agency's tentative
approval means that though existing patents or exclusivity agreements prevent
U.S. marketing of the products, the drug meets FDA's standards for quality,
safety, and effectiveness. Generic Viramune (nevirapine) -- an "antiretroviral"
drug that helps keep the AIDS virus from reproducing-- is used in combination
with other antiretroviral drugs.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01187.html
Aptivus (tipranavir) Approved for HIV Patients with
Advanced Disease
FDA's approval of Aptivus provides a new
therapy for patients with limited treatment options. Aptivus, manufactured
by Boehringer Ingelheim Pharmaceuticals, Inc., is to be taken along with
ritonavir. Studies showed that 200 mg of ritonavir twice daily boosted the
level of Aptivus and lowered the amount of virus in the blood more than patients
who took other currently available anit-HIV medicines.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01189.html
Heart Failure Drug BiDil Approved for Black
Patients
In a move that represents a step toward the promise of
personalized medicine, FDA has approved BiDil for the treatment of heart failure
in black patients. Study results showed that black patients experienced a
43 percent reduction in death and an 39 percent decrease in hospitalization for
heart failure compared to placebo. BiDil is marketed by NitroMed, Inc. of
Lexington, Mass.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01190.html
Generic AIDS Drug Efavirenz Gets Tentative
Approval
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01191.html
Food Safety Tips for a Safe and Healthy
4th of July
Be sure that the only fireworks this Independence
Day and all summer long are in the sky and not in your stomach by following
proper food-handling techniques. Keeping cold foods cold, hot foods hot,
and other important food safety tips will protect yourself, your family and
friends from food-borne illness and food contamination.
http://www.cfsan.fda.gov/~dms/fssummer.html
FDA/USDA Safety Measures Kept BSE-Positive Cow Out of
Food Supply
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01193.html
Acting Commissioner Crawford,
Singapore's Tan Sign MOU (Photo Release)
http://www.fda.gov/bbs/topics/news/photorelease/photo062405.html
To view an archive of past 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.]
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RECALLS/SAFETY
ALERTS
Recalls:
Vail Products
Issues Nationwide Recall of Enclosed Bed Systems
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01194.html
Safety Information and Corrective Action about Guidant
Implantable Cardiac Defibrillators
http://www.fda.gov/oc/po/firmrecalls/guidant062405.html
Mariani Brand Fancy Golden Raisins (30-lb. boxes)
Reason
for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/setton06_05.html
690 cases of Catherine's Finest Pecan Caramel Clusters (8-oz.
size; 85 cases of Shwom's Caramel Pecan Clusters (6-oz. size)
Reason for
recall: undeclared soy
http://www.fda.gov/oc/po/firmrecalls/barricini06_05.html
Dried Vegetable (4 oz. plastic
bags)
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/orientalhouse06_05.html
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.]
__________________________________________________
PUBLIC
MEETINGS
June 28 -- Pediatric Ethics
Subcommittee of the Pediatric Advisory Committee
Under discussion: a proposed clinical investigation involving
children as subjects
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/fda12605d062805.html
June 29-30 -- Pediatric Advisory
Committee
Under discussion: a proposed clinical investigation involving
children as subjects and discussion of a report on adverse event reporting for
methylphendidate
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/fda12604dd06293005.html
For a list of FDA meetings, seminars, and other
public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________
QUESTION
OF THE WEEK
How can you find more information about
clinical trials?
To learn more about clinical trials of new drugs and
medical devices, go to http://www.clinicaltrials.gov.
__________________________________________________
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