Navigation Links
FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
Date:5/26/2009

Conference Call to be Held at 9:00 a.m. Eastern Time Today, May 26, 2009

SILVER SPRING, Md., May 26 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

"Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The FDA's action in approving once-a-day ADCIRCA is a big plus for all three P's: patients, physicians and payors."

In the PHIRST-1 randomized, double-blind, 16-week placebo-controlled Phase 3 clinical trial of ADCIRCA for PAH, patients taking ADCIRCA 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking ADCIRCA 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushin
'/>"/>

SOURCE United Therapeutics Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
2. FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
3. FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation
4. FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
5. FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
6. FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes
7. FDA Approves Bayer HealthCares Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A
8. F.D.A. Approves SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
9. FDA Approves First Hepatitis B Viral Load Test
10. U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinsons Disease
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... membrane market has witnessed robust development with the growth pace ... later starter. In 2012, the size of China ... the proportion worldwide soaring to 16.3%. It is projected that ... its growth rate by around 20% in the upcoming years ... RMB25 billion. An integrated membrane industrial system has ...
(Date:12/17/2014)... , December 17, 2014 Revenue ... of expenditure on research and development In the ... its revenue by two percent to EUR 4.287 billion (last ... grew by 14 percent to EUR 360 million. "Overall, 2013/14 ... Dr. Michael Kaschke , President and CEO of Carl ...
(Date:12/17/2014)... NEW YORK , Dec. 17, 2014 /PRNewswire-USNewswire/ ... resonance imaging (MRI), the MRI market is seeing ... cardiovascular and breast MRI scans account for the ... providing a higher resolution of images, which are creating ... resonance imaging (MRI) market is growing at a ...
Breaking Medicine Technology:Separation Membranes Market (Company, Country & Application) Research Reports for Global and Chinese Regions 2Separation Membranes Market (Company, Country & Application) Research Reports for Global and Chinese Regions 3ZEISS Asserts its Position in Difficult Environment 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 3
... challenges of treating acne in a clinical setting are ... program that provides physicians with a viable alternative to ... to bridge the gap between science and skin health ... Light device. The TRIA |MD referral program ...
... WORCESTER, Mass. and TORONTO, Aug. 2, 2011 Generex ... to provide its shareholders with a corporate update of ... Mark Fletcher as President & Chief Executive Officer on ... President & Chief Executive Officer of Generex, I have ...
Cached Medicine Technology:TRIA Beauty Leading the Charge in Bridging Gap Between Science and Skin Health 2TRIA Beauty Leading the Charge in Bridging Gap Between Science and Skin Health 3Generex Provides Corporate Update 2Generex Provides Corporate Update 3Generex Provides Corporate Update 4Generex Provides Corporate Update 5Generex Provides Corporate Update 6Generex Provides Corporate Update 7Generex Provides Corporate Update 8
(Date:12/21/2014)... (PRWEB) December 22, 2014 Recently, BambooFlooringChina.com, ... durable strand woven bamboo flooring collection , and launched ... 25%. The promotion is valid until Jan. 30, 2015. ... woven bamboo is the hardest bamboo flooring available today; ... resembling that of traditional teak hardwoods. Strand woven bamboo ...
(Date:12/21/2014)... BellasDress.com offers a wide range of women’s dresses, ... its BellasDress Christmas Sale , offering big discounts ... BellasDress is a famous online supplier of women’s dresses; ... series of promotions. The dress experts of the company ... are proud of offering high quality wedding dresses and ...
(Date:12/21/2014)... Gables, FL (PRWEB) December 21, 2014 When ... head lice, who do they call? The new answer is ... Blvd, Coral Gables FL 33134, their newest treatment center will ... this pest quickly, conveniently and without the use of harmful ... Opening is scheduled for January 1, 2015. Like the company’s ...
(Date:12/21/2014)... York, New York (PRWEB) December 21, 2014 ... ) and other product liability claims involving a ... incretin mimetics continue to move forward in a ... Court, Southern District of California, Bernstein Liebhard LLP ... the Court has established a data cut-off date ...
(Date:12/21/2014)... Recently, one of the best prom dresses online shops ... introduced its new collection of 2015 prom dresses, and ... its prom dresses & other fashionable designs, up to ... quality dress products and great customer services to its ... the best prom dresses online shops around the world ...
Breaking Medicine News(10 mins):Health News:BambooFlooringChina.com Announced Its Durable Strand Woven Bamboo Flooring Collection 2Health News:BellasDress.com Announces its BellasDress Christmas Sale 2Health News:All-Natural Florida Lice Removal Company Opens New Lice Treatment Salon In South Florida 2Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 2Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 3Health News:Byetta Lawsuit News: New Order Issued in Federal Incretin Mimetics Litigation, Bernstein Liebhard LLP Report 4Health News:New Prom Dresses From One Of The Best Prom Dresses Online Shops, LunaDress Prom Shop 2
... slipping while walking off a curb, may seem relatively harmless, ... elderly individuals, according to a new study published in The ... As the population continues to age, it is important for ... deal with this issue, which could significantly impact the overall ...
... Helicobacter pylori , a common stomach bacterium, reduced the severity ... mice, according to research from U-M Medical School scientists. More ... H. pylori , although it is very unusual to find it ... an inflammation control benefit to hosting the H. pylori ...
... calling for clear guidelines on childhood stroke after a study, ... found wide variations in time lag to diagnosis, investigation and ... of appropriate rehabilitation services, after a follow-up study found that ... dysfunction or limitations. Dr Sten Christerson studied ...
... -- Hepatitis C patients who receive a liver from a ... who receive a liver from a black donor, researchers have ... receive a liver from a white donor, the study authors ... at 165 hepatitis C patients who received a liver transplant ...
... common, but they,ve lacked a reliable screening test for it. ... and Group Health report the PHQ-9 (Patient Health Questionnaire - ... in adolescents. Led by Laura P. Richardson, MD, ... for depression in 442 teenage patients, age 13-17, at Group ...
... An overwhelming majority of Breast Cancer Surveillance Consortium (BCSC) ... U.S. are up-to-par with American College of Radiology Imaging ... technical standards and requirements, according to a study in ... College of Radiology ( www.jacr.org ). The BCSC is ...
Cached Medicine News:Health News:For elderly, even short falls can be deadly 2Health News:For elderly, even short falls can be deadly 3Health News:Common stomach bacteria may fight off inflammatory bowel disease caused by Salmonella 2Health News:Common stomach bacteria may fight off inflammatory bowel disease caused by Salmonella 3Health News:Childhood stroke study identifies the contraceptive pill and smoking as risk factors 2Health News:Childhood stroke study identifies the contraceptive pill and smoking as risk factors 3Health News:Maj. of comm. facilities performing breast MRI exams meet ACRIN and EUSOBI technical requirements 2