Navigation Links
Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Lamivudine and Zidovudine Tablets, 30 mg/60 mg
Date:1/20/2011

PITTSBURGH, Jan. 20, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg. The NDA is based on the reference listed drug Combivir®, by ViiV Healthcare. This innovative pediatric fixed-dose combination (FDC) in tablet form was developed by Matrix for use in treating children with HIV/AIDS. This product will be eligible for purchase outside the U.S. in certain developing countries.

Mylan President Heather Bresch said: "The approval of Lamivudine and Zidovudine is particularly important because it makes available an innovative FDC treatment option for children who are living with HIV/AIDS in developing countries. The addition of this product to our ARV franchise is a critical next step in helping to extend and improve the quality of life of people living with HIV/AIDS and to continue to expand access to high quality, affordable ARVs."

Lamivudine and Zidovudine Tablets, a combination of two nucleoside analogue reverse transcriptase inhibitors, are used in combination with other medications to control HIV infection. The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Matrix's wide range of ARV products includes active pharmaceutical ingredients and 34 first- and second-line finished doses, eight of which are pediatric products. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in developing countries depend on a Matrix ARV product.

Mylan Inc. rank
'/>"/>

SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related medicine technology :

1. Matrixx Initiatives, Inc. and H.I.G. Capital Announce Early Termination of HSR Waiting Period
2. First Patient Enrolled in Multi-Center Clinical Trial of the CorMatrix® ECM® for Pericardial Closure to Reduce the Incidence of New Onset Postoperative Atrial Fibrillation
3. SRI International and PhenoMatriX Collaborate to Develop Platin-Based Chemotherapies
4. National University Hospital Singapore Operates on Asias 1st TRAM Flap Patient Using TIGR® Matrix Surgical Mesh, the Worlds 1st Long-Term Resorbable Mesh
5. Collagen Matrix, Inc. Expands Operations and Moves Corporate Headquarters to Oakland, New Jersey
6. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 Second Quarter Financial Results
7. National University Hospital Singapore Receives DSRB Approval to Use TIGR® Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
8. CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
9. DynaMatrix™ to be Featured on Discovery Channel Segment Highlighting Innovative Products in Oral Health
10. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2011 First Quarter Financial Results
11. Novus Scientific Announces the Sales Launch for TIGR™ Matrix Surgical Mesh - Worlds 1st Long-Term Resorbable Synthetic Mesh
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... /PRNewswire-iReach/ -- It is no secret that Americans have an ... obese gyms and supplement companies are in line to make ... related to dietary issues and a lack of physical activity ... glandular problem or even a vitamin deficiency. (Photo: ... a lack of vitamin b12 . The vitamin is ...
(Date:5/20/2013)... May 20, 2013   National Community Pharmacists Association ... , RPh, MBA issued the following statement today regarding ... Medicare Part D "preferred pharmacy" drug plans , ... the plan,s lowest advertised co-payments: (Logo:  ... and MedPAC , 16 U.S. Senators ...
(Date:5/20/2013)... 20, 2013 /PRNewswire-iReach/ -- Today at American Society ... Christine Ginocchio discussed Specific Technologies blood ... identification of microorganisms producing bloodstream infection. Dr. Ginocchio ... the Division of Infectious Disease Diagnostics at North ... non-sectarian health system. (Photo: http://photos.prnewswire.com/prnh/20130520/CG16829 ...
Breaking Medicine Technology:USB12Shots.com Discusses the Possibility of B12 Shots for Weight Loss 2Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 2Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 3Poll: Over One Million Seniors Have Problems with Medicare 'Preferred Pharmacy' Drug Plans 4Specific Technologies Bloodstream Infection Identification Solutions Discussed at the American Society for Microbiology Conference by Award Lecturer Christine Ginocchio 2Specific Technologies Bloodstream Infection Identification Solutions Discussed at the American Society for Microbiology Conference by Award Lecturer Christine Ginocchio 3
... 1 InterMune, Inc. (Nasdaq: ITMN ) today announced ... InterMune, will present at the Fourth Annual JMP Securities Healthcare ... 3:30 p.m. EDT. , To access a live ... may log on to the investor relations page of InterMune,s ...
... announced today that it has entered into a binding agreement ... Fovea has a portfolio of three clinical compounds, a unique ... the eye diseases. The deal is valued to a total ... milestone payments related to the progress of the clinical compounds. ...
Cached Medicine Technology:Fovea Pharmaceuticals to be Acquired by sanofi-aventis 2
(Date:5/21/2013)... Urban elementary school children with poorly controlled asthma ... academically, new research indicates. "In our sample ... found that compromised lung function corresponded with both ... study author Daphne Koinis-Mitchell, an associate professor ... Alpert Medical School in Providence, R.I. Koinis-Mitchell, ...
(Date:5/21/2013)... -- The monstrous tornado that devastated Moore, Okla., ... is a stunning example of violent weather that ... even thunderstorms with lightning and strong winds can ... Some anxiety in the face of violent ... phobias that interfere with their everyday lives, said ...
(Date:5/21/2013)... has awarded New York University neuroscientist J. Anthony Movshon ... his "pioneering work on the neuroscience of vision." ... Neural Science, is the second NYU neuroscience professor to ... the honor in 2011 in recognition of his "seminal ... fear learning, and fear memory." , Movshon, a ...
(Date:5/21/2013)... 2013 Residents in St. Petersburg, FL ... now that Dr. David Sherberg, DMD, has joined Coast ... Dr. Sherberg provides preventive, restorative and cosmetic dentistry to ... friendly team provide a wide variety of services ... canal therapy, crowns, bridges, dentures, dental implant restorations, veneers, ...
(Date:5/21/2013)... Benefit Express Services, LLC, a leader in ... will be hosting a free Workplace Wellness webinar on ... The presentation will focus on making sure your workplace ... Health Care Reform Requirements. The team will also share ... Express regularly hosts free educational webinars on issues that ...
Breaking Medicine News(10 mins):Health News:Sleepless Nights May Hurt School Performance of Kids With Asthma 2Health News:Weather Worries Can Threaten a Child's Mental Health 2Health News:NYU's Movshon receives Lashley Award for his research on the neuroscience of vision 2Health News:Coast Dental Pasadena Welcomes Dr. David Sherberg 2Health News:Coast Dental Pasadena Welcomes Dr. David Sherberg 3Health News:Benefit Express to Host Workplace Wellness Webinar 2
... Itamar Medical ... ... Medicine, Mayo Clinic, Rochester, MN Dr. Peter Friberg, Sahlgrenska University ... Mr. Israel Schreiber, President and CEO, Itamar Medical ...
... reduced heart risks after angioplasty/stenting, but raised bleeding risks ... -- A new anti-clotting drug might one day challenge Plavix, ... procedures to open blocked coronary arteries, a new study suggests. ... -- notably those who had had a prior stroke, were ...
... ORLANDO, FL A North Carolina team of doctors, ... up with a way to provide faster, more effective ... require expensive drugs or fancy new equipment. But it ... on everyone involved to move treatment forward empowering ...
... Calif., Nov. 4 Consistent implementation of,proven ... to a Kaiser,Permanente (KP) abstract, published this ... in Orlando, Florida. The researchers followed ... to Kaiser Permanente emergency departments in Northern,California ...
... research suggests , , SUNDAY, Nov. 4 (HealthDay News) ... typically need open-heart surgery might someday have a new, ... , The balloon is inserted percutaneously (through the skin), ... said. In a new study, the procedure -- not ...
... risk of major cardiovascular events by 19, percent, significantly ... ... bleeding, TOKYO and INDIANAPOLIS, Nov. 4 ... investigational,antiplatelet agent prasugrel produced a highly significant 19 percent,reduction in relative ...
Cached Medicine News:Health News:How Early Can We Detect Cardiovascular Disease Less Expensively ... Even in Childhood? 2Health News:New Anti-Clotting Drug Shows Promise in Heart Patients 2Health News:New Anti-Clotting Drug Shows Promise in Heart Patients 3Health News:RACE: a statewide model of better, faster heart attack care 2Health News:RACE: a statewide model of better, faster heart attack care 3Health News:Following Heart Disease Guidelines Saves Lives, According to a Kaiser Permanente Abstract Presented at AHA Scientific Sessions 2Health News:Following Heart Disease Guidelines Saves Lives, According to a Kaiser Permanente Abstract Presented at AHA Scientific Sessions 3Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 2Health News:Balloon Valve May Be Alternative to Open-Heart Surgery 3Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 2Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 3Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 4Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 5Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 6Health News:In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack 7
... imaging camera system designed for scientific ... megapixel digital cameras provides high-resolution, full-color ... on a PC via its Firewire ... previewing capability is accompanied by automatic ...
... digital output. Three-chip color camera for brightfield, ... of high-quality color video cameras give you ... need for an efficient viewing experience. These ... of your specimen that can be easily ...
... The PM20 is a fully automatic fluorescence ... quality photomicrographs of even the most difficult ... the new PM20 system provide solution to ... addition to their automatic exposure control, the ...
... photomicrography system that greatly simply taking ... difficult specimens. Designed with real life in ... to the complex problem of fluorescence photomicrography. ... the system utilizes special programs designed to ...
Medicine Products: