Navigation Links
Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets
Date:12/4/2007

PITTSBURGH, Dec. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that 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 Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300 mg. Matrix's Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc.'s Viread Tablets, 300 mg.

Matrix's ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by Matrix within the last 12 months. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment in certain countries outside of the United States. Although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing in the United States, which helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public.

Mylan Vice Chairman and CEO Robert J. Coury said: "This is yet another milestone for Mylan and Matrix and their commitment to the Company's growing antiretroviral (ARV) franchise that includes active pharmaceutical ingredients (API) and finished dosage forms for first- and second-line treatments. We applaud Matrix for its high quality science and manufacturing capabilities that resulted in earning this important tentative approval in such a short timeframe. Tenofovir Disoproxil Fumarate will help to meet the urgent and increasing need for hig
'/>"/>

SOURCE Mylan Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
2. Mylan Announces Appointment of David A. Lillback as Senior Vice President and Global Head of Human Resources
3. Mylan Announces Final FDA Approval for Carvedilol Tablets
4. Mylan Announces Tentative FDA Approval for Topiramate Capsules
5. Mylan Announces Appointment of M. Fabiana Lacerca as Senior Vice President and Chief Compliance Officer
6. Mylan Announces Extension of Tender Offers for Its 5.750% Senior Notes due 2010 and 6.375% Senior Notes due 2015
7. Mylan Announces Appointment of Brian Byala as Senior Vice President and Treasurer
8. Mylan Announces Appointment of Didier Barret as President, Europe, Middle East and Africa
9. Mylan Announces Appointment of Harry A. Korman as President, North America
10. Mylan Announces Appointment of John Montgomery as President, Asia Pacific
11. Mylan Announces Management of Specialty Business, Dey L.P.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... 20, 2014 With a mere 19 ... Crist made a brief fundraising stop at the ... , Fresh from a debate last night with his ... stage for the first seven minutes because Crist had ... described the incident in one word: "weird." , Before ...
(Date:10/20/2014)... 2014 T.E.N., a technology and ... today that William H. Murray, renowned author and ... Luminary Leadership Award winner. Presented annually, the ISE® ... outstanding leader and industry practitioner for his or ... the information security industry. , Formerly with IBM, ...
(Date:10/20/2014)... 2014 Principle Business Enterprises, a family ... manufacturing top-of-the-line absorbent products. The company has recently ... popular brand, Tranquility® Premium Protection absorbent products. The ... gave its packaging a new look, and is currently ... to the public. , The new website, developed with ...
(Date:10/20/2014)... 20, 2014 Based on a ... only imaging assays capable of determining DNA sequence, ... With these three dimensions of high-resolution data, dGH ... the widest range of disease-causing genetic rearrangements, including ... other genomic tools, including today’s advanced sequencing technologies. ...
(Date:10/20/2014)... 2014 Punzoné , the first line ... has a lot to celebrate this month. October marks Italian ... achievements and contributions of Americans of Italian heritage and Italians ... today it shares its favorite Italian cocktails and encourages everyone ... - even if it is only in a glass. ...
Breaking Medicine News(10 mins):Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 2Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 3Health News:Bill Murray named 2014 ISE® Luminary Leadership Award Winner 4Health News:Tranquility® Premium Protection Incontinence Products Releases New Logo and Website 2Health News:KromaTiD Launches Genome Screening and Discovery Services 2Health News:KromaTiD Launches Genome Screening and Discovery Services 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4
... Attorney General Eric Holder announced today that ... in Recovery Act formula grants for Florida state victim assistance ... in his remarks at the National Crime Victims, Rights Week ... Raton, Fla., for his efforts on behalf of ...
... same that sickened seven people in California, Texas , , FRIDAY, ... Friday to try to contain a swine flu outbreak that ... and sickened more than 900 other people in recent weeks. ... the start of a flu pandemic, according to published reports. ...
... thousand homecare workers won a partial victory today as an ... cuts "perverse" and ordered the board to lessen the severity ... six months to a smaller cut over a period not ... new proposal last week to cut healthcare for the workers ...
... are going unmet, , , FRIDAY, April 24 (HealthDay News) ... for them, want more attention paid to their psychological ... and their caretakers suffer in a variety of ways," ... at the University of Colorado Health Sciences Center, who ...
... the role of prostaglandins a family of fatty ... pressure maintenance, researchers at the University of Pennsylvania School ... the receptor for one type of prostaglandin have lower ... , The results indicate that the normal role ...
... 99 Percent for PUR Faucet Filters and More Than ... Associated Press issued a new report on ... water. Pharmaceuticals have now been detected in the drinking ... scientists have found no evidence of adverse health effects ...
Cached Medicine News:Health News:Attorney General Eric Holder Honors Florida Doctor and Announces $4.7 Million in Recovery Act Funds for State 2Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 2Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 3Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 4Health News:At Least 20 Dead, Hundreds Ill in Swine Flu Outbreak in Mexico 5Health News:Arbitrator Calls Fresno Board of Supervisors' Planned Cuts to Homecare Workers 'Perverse'; Orders Cuts Reduced 2Health News:Reduce Suffering, Urge Heart Failure Patients and Caregivers 2Health News:Reduce Suffering, Urge Heart Failure Patients and Caregivers 3Health News:New target for maintaining healthy blood pressure discovered 2Health News:New target for maintaining healthy blood pressure discovered 3Health News:PUR Water Filtration Systems Can Reduce Trace Levels of Pharmaceuticals Found in Some U.S. Tap Water 2Health News:PUR Water Filtration Systems Can Reduce Trace Levels of Pharmaceuticals Found in Some U.S. Tap Water 3
(Date:10/20/2014)... DIEGO , Oct. 20, 2014   BioNano Genomics ... Irys system: the ability to collect human data at 30X ... a single chip.  This new capability was established and demonstrated ... the Irys TM System and will be ... two months. BioNano will be showcasing this advancement at the ...
(Date:10/20/2014)... DIEGO , Oct. 20, 2014 ... industry leader in bioactive lipid-targeted therapeutics, received official notification ... has been granted another key patent supporting its ... newly issued patent, European patent No. 2087002, claims ... substance in Lpath,s two lead compounds, iSONEP and ...
(Date:10/20/2014)... -- Norgine B.V. today announced that the ... preparation, NER1006, presented at the 79 th Annual ... Philadelphia, PA , has met its ... endpoint of cleansing success. The study demonstrated high quality ... in screening colonoscopy patients. [1] (Logo: ...
Breaking Medicine Technology:BioNano Genomics Announces One Human : One Chip : One Day 2BioNano Genomics Announces One Human : One Chip : One Day 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 2Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 4Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy 2
... DIEGO , May 6 Orexigen® Therapeutics, Inc. (Nasdaq: OREX ... financial results for the first quarter ended March 31, 2010 on ... followed by a live webcast and conference call at 5:00 p.m. Eastern ... Orexigen management will ...
... , May 6 DUSA Pharmaceuticals, Inc. ( DUSA ) announces that its corporate ... 6:30 a.m. to be followed by a conference call at 8:30 a.m. , ... - 8:30 a.m. E.T. , , , ... , , 800-647-4314 , ...
Cached Medicine Technology:Orexigen(R) Therapeutics Schedules May 10, 2010 Webcast Discussion of Financial Results for the First Quarter Ended March 31, 2010 2DUSA Pharmaceuticals, Inc.(R) to Host First Quarter 2010 Corporate Highlights and Financial Results Conference Call 2
... The Original LMA™ Airway., ,Launched in ... its use is now standard practice in ... patients worldwide the LMA Classic™ is a ... , ,The LMA Classic™ can be ...
... The Intubating LMA™ Airway. , ... or unexpected difficult airway, the LMA Fastrach™ ... without moving the head or neck. The ... attempts. , ,Selected by emergency teams ...
... The King LT™ is a superior, ... latest technological advances in materials and design ... The King LT™ emergency airway is a ... to provide emergency ventilation when direct laryngoscopy ...
... Soft amber latex. Available in even ... nasal airway maximizing patient comfort., ... way to maximize patient comfort while ... sensitivity. It is economically priced allowing ...
Medicine Products: