Navigation Links
Mylan Launches Generic Version of Plavix® Tablets
Date:5/17/2012

PITTSBURGH, May 17, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel Tablets USP, 75 mg and 300 mg. The company was the first to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Clopidogrel Tablets, 300 mg, and was awarded 180 days of marketing exclusivity for this strength. This product is the generic version of Sanofi-Aventis' Plavix® and is indicated for acute coronary syndrome and for patients with a recent history of myocardial infarction, stroke or established peripheral arterial disease.[1]

Mylan Pharmaceuticals will provide customers with the 75 mg strength of this product in bottle form, and Mylan Institutional, which serves the institutional pharmaceutical market, will supply the 300 mg strength exclusively in unit dose packs of 30. This business also will supply Clopidogrel Tablets, 75 mg, in unit dose packs of 100. Mylan is shipping all product presentations immediately.

Plavix Tablets, 75 mg and 300 mg, had U.S. sales of approximately $6.7 billion for the 12 months ending March 31, 2012, according to IMS Health.

Currently, Mylan has 173 ANDAs pending FDA approval representing $98.2 billion in annual sales, according to IMS Health. Thirty-nine of these pending ANDAs are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com 


[1] Clopidogrel has been shown to be less effective in people who are known as "CYP2C19 poor metabolizers."  A blood test is used to determine if a person is a poor metabolizer. Clopidogrel is not indicated in those who are allergic to it or have active bleeding. Clopidogrel can increase the risk of bleeding and should be discontinued five days before surgery. Premature discontinuations can increase the risk for cardiovascular events and in patients who have had a recent transient ischemic attack or stroke. The combination of clopidogrel and aspirin can increase major bleeding. Fatal thrombotic thrombocytopenic purpura has also been reported.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Launches Generic Lipitor® in Five European Countries
2. Mylan Reports Q1 2012 Adjusted Diluted EPS of $0.52, an 18% Increase Over Prior Year Quarter
3. Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement with Teva
4. Mylan Launches Generic Version of Zyprexa® Tablets
5. Mylan Launches First Generic Version of Lescol® Capsules
6. Mylan Schedules First Quarter 2012 Financial Results Conference Call and Live Webcast
7. Mylan One of First to Launch Generic Version of Boniva®
8. Mylan Canada Receives Health Canada Approval for Generic Version of Crestor®
9. Mylan Continues to Pursue Damages and Injunction Against Sunovions Brovana® in Ongoing Litigation
10. Mylan Pharmaceuticals President Tony Mauro Elected Chairman of GPhA
11. Mylan Secures an Additional $300 Million of Committed Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... AVACEN Medical (AVACEN) announced that its CE-Marked ... those with the widespread pain associated with fibromyalgia in ... Essex, England commented, "I had ... no sleep at all, tremendous pain, with every movement ... [the AVACEN 100] enough, how this has and is ...
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
(Date:9/12/2017)...  ValGenesis Inc., the global leader in Enterprise ... announce the appointment of Dr. Ajaz Hussain ... Directors and Chairman of Advisory Board beginning September ... to manage their entire validation lifecycle process electronically ... process. Furthermore, ValGenesis VLMS enables rigorous compliance, helps ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many ... event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids ... of all ages; it is a non-competitive, non-timed event, which is all about having ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/12/2017)... WILMINGTON, Del. (PRWEB) , ... October 12, 2017 ... ... technology and advisory services for healthcare compliance program management, will showcase a range ... and National Association for Assisted Living (NCAL) Convention and Expo to be held ...
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
Breaking Medicine News(10 mins):