Navigation Links
FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
Date:3/2/2010

Condition known as benign prostatic hyperplasia common in older men

SILVER SPRING, Md., March 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The most common symptoms of BPH include a weak stream during urination, urgency, leaking or dribbling, as well as more frequent urination, especially at night.

BPH is common among older men. According to the National Institutes of Health, it rarely causes symptoms before age 40, but more than half of men in their 60s and as many as 90 percent of men older than 70 have BPH symptoms.

"The approval of generic tamsulosin offers greater access to a widely used treatment for BPH," said Gary Buehler, director of the FDA's Office of Generic Drugs. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."

The prescribing information and safety warnings for the generic version of tamsulosin are the same as those for Flomax Capsules. Generic tamsulosin capsules are manufactured by IMPAX Laboratories Inc. of Haywood, Calif. Information about the marketing and availability of this generic drug can be obtained from the manufacturer.

For more information

Consumer Information: Generic Drugs

http://www.fda.gov/Drugs/ResourcesForYou/ucm167906.htm

What BPH Means to Men – A Healthy Moments Podcast from the National Institutes of Health

http://www2.niddk.nih.gov/HealthEducation/HealthyMoments/04_06_2009.htm

Information on specific drug products, Drugs@FDA

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Back to top

RELATED LINKS
http://www.fda.gov/

'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves First New Inhaled Antibiotic for CF in More Than a Decade
2. FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinsons Disease
3. FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
4. FDA Approves Xiaflex for Debilitating Hand Condition
5. FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
6. Chinese State Food and Drug Administration Approves Company Facility for Producing Solid Dosage Perindopril
7. FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
8. FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
9. FDA Approves Lillys ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
10. FDA Approves Lillys Zyprexa for Two Adolescent Indications
11. US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... India , February 5, 2016 ... a new market research report "Fetal (Labor & Delivery) ... & Antepartum), Warmer, Incubator, Pulse Oximeter, Phototherapy/Jaundice Management Devices, ... published by MarketsandMarkets, This report studies the global market ... market is estimated at USD 6.28 Billion in 2015 ...
(Date:2/4/2016)... 2016 For hospitals considering enrollment in the ... in the program, the Health Resources and Services Administration,s ... , Mega-Guidance , could have significant impact on plans ... September 2016. Essential Insights , Daniel ... summarizes the Mega-Guidance,s key proposed changes, including a new ...
(Date:2/4/2016)... , Feb. 4, 2016  SciClone Pharmaceuticals, ... announced it has entered into a settlement agreement ... (SEC) fully resolving the SEC,s investigation into possible ... Under the terms of the settlement agreement, SciClone ... million, including disgorgement, pre-judgment interest and a penalty.  ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the air at King ... colors, assortments and packaging. This staple for Valentine’s Day is a must-have, and can ... For Valentine’s Day, not only are long-stem roses available, but also other flower bouquets, ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... stage for new clinical and scientific initiatives have all marked the last 12 ... appointed President and CEO of the nation’s oldest cancer center, Candace S. Johnson, ...
(Date:2/5/2016)... ... February 05, 2016 , ... Francisco ... micro-needling services in their Napa Valley office. The technique utilizes the body’s own ... Dr. Canales and Dr. Furnas, are part of only a select few cosmetic ...
(Date:2/5/2016)... ... ... After years as an active staff surgeon and having served as the director ... transitioned to chief of the Division of Plastic Surgery at what is now known ... began a second three-year term in January of 2016. , The original selection was ...
(Date:2/5/2016)... ... February 05, 2016 , ... In the fourth quarter ... gathered at the La Valencia Hotel in San Diego, California to discuss changes ... the year’s most outstanding franchise, walking away with the coveted David Wright Award ...
Breaking Medicine News(10 mins):