Navigation Links
Mylan Receives Tentative FDA Approval for Generic Version of Lipitor®
Date:2/2/2012

PITTSBURGH, Feb. 2, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base). Atorvastatin Calcium is the generic equivalent to Pfizer's Lipitor® Tablets, indicated for the prevention of cardiovascular disease and hypercholesterolemia.

Lipitor had U.S. sales of $8.2 billion for the twelve months ending Dec. 31, 2011, according to IMS Health.

Currently, Mylan has 173 ANDAs pending FDA approval representing $98.5 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.8 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

 


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

Page: 1

Related medicine technology :

1. Mylan to Host Investor Day on Feb. 21, 2012, in New York City
2. Mylan Launches Innovative Version of Antiepileptic Drug Levetiracetam
3. Mylan Launches First Generic Version of Teveten® Tablets
4. Mylan Receives Approval for First-to-File Generic Keppra XR® Extended-Release Tablets
5. Mylan Receives WHO Approval for Innovative Second-Line-in-a-Box HIV/AIDS Treatment
6. Mylan Launches Generic Version of Toprol-XL® Tablets
7. Mylan Names John Thievon President of Dey Pharma
8. Mylan Launches Generic Version of Cyklokapron® Injection
9. Mylan Receives Tentative FDA Approval Through PEPFAR for First Heat-Stable, Fixed-Dose Combination of Atazanavir Sulfate and Ritonavir Tablets for HIV/AIDS
10. Mylan Launches Generic Version of Caduet® Tablets
11. Mylan Confirms First-to-File Patent Challenge Relating to Generess™ Fe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... Texas , May 25, 2016 ... the issuance to it by the US Patent ... The company,s technology includes proprietary processes for electronic ... for health and wellness programs, HIPAA compliance and ... "Our technology ...
(Date:5/25/2016)... 25, 2016 ReportsnReports.com adds ... report that provides an overview on therapeutic pipeline ... various stages, therapeutics assessment by drug target, mechanism ... molecule type, along with latest updates, and featured ... players involved in the therapeutic development for Chronic ...
(Date:5/24/2016)... LONDON , May 24, 2016 ... erfüllt beide primären Endpunkte ... und Überlegenheit in ‚ausgezeichneter plus guter ... aufsteigenden Colons    ,      (Logo: ... B.V. gab heute neue positive Daten von der ...
Breaking Medicine Technology:
(Date:5/28/2016)... ... 28, 2016 , ... "Color Grading media can be time consuming but with ... media," said Christina Austin - CEO of Pixel Film Studios. , With the ... stylish color grades to their footage. A LUT is a Lookup Table that contains ...
(Date:5/28/2016)... , ... May 28, 2016 , ... In a part of the city where’s it’s ... new farm-to-table Kelowna restaurants is hoping to attract diners with a taste for ... Suites officially opened the doors to Cornerstone Grill, an urban casual restaurant focusing on ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... Two director-level ... as YWCA Tribute to Women and Industry (TWIN) 2016 honorees. The award recognizes ... workplace. For this year, Geri Boone, Director of the MLTSS (Managed Long-Term Services and ...
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent of acute ... for a sustainable product to aid in the rehabilitation process has steadily increased. Ekso ... of individuals with hemiplegia due to stroke. , Ekso Bionics has now received clearance ...
(Date:5/27/2016)... ... May 27, 2016 , ... In response ... many who are unaware of the plight of aphasia. In collaboration with the ... “Stroke Awareness” campaign. , The link between stroke and aphasia is relatively unknown, ...
Breaking Medicine News(10 mins):