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:4/20/2017)... LUND, Sweden , April 20, 2017 /PRNewswire/ ... OTCQX: NEVPF) ("NeuroVive") today announced positive preclinical ... company,s preclinical compound for non-alcoholic steatohepatitis (NASH), ... NV556 has previously ... STAM™ NASH model. Today, NeuroVive,s scientists present ...
(Date:4/19/2017)...  IRIDEX Corporation (Nasdaq: IRIX ) today ... first quarter 2017 after the close of trading on ... host a corresponding conference call beginning at 2:30 p.m. ... in listening to the conference call may do so ... 326-3030 for international callers, using conference ID: 92158987.  A ...
(Date:4/19/2017)... DIEGO , April 19, 2017  Sorrento ... an antibody-centric, clinical-stage biopharmaceutical company developing new treatments ... announced the closing of its previously announced underwritten ... stock at a public offering price of $2.00 ... and estimated offering expenses payable by Sorrento.  The ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... April 25, 2017 , ... ProRehab Physical Therapy ... the preferred physical therapy provider for Derby City CrossFit, effective immediately. , In ... as quickly and effectively as possible, ProRehab’s sports physical therapists will work with ...
(Date:4/25/2017)... (PRWEB) , ... April 25, 2017 , ... ... Liberty attempts to compare student test score performance for the 2015-16 school year ... the state’s voucher programs. Though it highlights important patterns in student test score ...
(Date:4/25/2017)... ... 2017 , ... As pharmaceutical companies are held to increasingly ... innovation in drug formulation and manufacturing. CoreRx offers its clients more than ... support of their development and manufacturing goals. , The company was created ...
(Date:4/25/2017)... ... , ... Saad B. Chaudhary, MD is committed to providing the highest quality of spine care ... on preventative care with all my patients to alleviate possible future issues. I am pleased ... contact my office and my trained staff will assist you in any way possible.” , ...
(Date:4/25/2017)... ... April 25, 2017 , ... Vetoquinol USA® , a ... UCII, part of the EQUISTRO line, at this week’s Rolex Kentucky Three-Day Event ... the immunologic level. , The scientifically-developed Flexadin UCII supports the body’s normal repair ...
Breaking Medicine News(10 mins):