Navigation Links
Mylan Receives Approval for Generic Version of Actigall(R)
Date:3/2/2010

PITTSBURGH, March 2 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules.

Ursodiol Capsules had U.S. sales of approximately $30 million for the 12 months ending Dec. 31, 2009 according to IMS Health. Mylan's version is available for immediate shipment.

Currently, Mylan has 142 ANDAs pending U.S. Food and Drug Administration approval representing $87.5 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, for the 12 months ending June 30, 2009, 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 140 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, please visit www.mylan.com.

SOURCE Mylan Inc.

Back to top

RELATED LINKS
http://www.mylan.com

'/>"/>

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

Related medicine technology :

1. Mylan Awarded NABP-VAWD Accreditation for Its Primary North American Distribution Facility
2. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
3. Mylan Receives Approval for Generic Version of GoLytely(R)
4. Mylan Declares Quarterly Preferred Stock Dividend
5. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
6. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
7. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
8. Mylan Added to NASDAQ-100 Index
9. Mylan Receives Approval for Generic Version of Antiepileptic Keppra(R) 1000 mg
10. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
11. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... February 10, 2016 Demonstrates ... 1 receptor selectivity   1 ... which has entered clinical development as a new ... and schizophrenia.   --> 1 ... has entered clinical development as a new treatment ...
(Date:2/9/2016)... Feb. 9, 2016  Landauer, Inc. (NYSE: LDR ... measurement and monitoring, outsourced medical physics services and high ... its fiscal 2016 first quarter ended December 31, 2015. ... Fiscal 2016 First Quarter Highlights , Revenue of ... quarter of 2015 , Domestic Radiation Measurement services revenues ...
(Date:2/9/2016)... BioSciences, Inc. (NASDAQ: SGMO ), the leader ... quarter and full year 2015 financial results and ... editing," said Edward Lanphier, Sangamo,s president and chief ... leads the therapeutic genome editing field and we ... our ground-breaking genome editing programs through IND enabling ...
Breaking Medicine Technology:
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... AxoGen, Inc. ... will report results for the fourth quarter and full year ended December 31, 2015 ... a conference call and webcast for the investment community following the release at 4:30 ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... measure change in their patients. Research shows that the Goal Attainment Scale (GAS) ... therapists overcome this challenge and learn more about the Goal Attainment Scale, Education ...
(Date:2/10/2016)... Palm Beach, Florida (PRWEB) , ... February 10, ... ... & Country Club) announced that it has been awarded the prestigious Distinguished Emerald ... the World award program conducted by BoardRoom magazine, one of the most respected ...
(Date:2/10/2016)... ... February 10, 2016 , ... The ... 26th: Amateur & Professional Divisions - Time: 7:00pm – 10:00pm | Ticket ... Ticket Prices $30, Social Media: http://www.USPoleSportsFed.org , Facebook: http://www.facebook.com/uspolesportsfederation , ...
(Date:2/10/2016)... ... February 10, 2016 , ... The recreational use of marijuana has been ... still face a lot of restrictions as to where they can smoke pot. ... use” and that cannabis “may not be consumed openly or publicly.” , Given the ...
Breaking Medicine News(10 mins):