Navigation Links
Mylan Receives Approval for Generic Version of Actigall(R)

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

SOURCE Mylan Inc.

Back to top



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:
(Date:12/2/2015)... 2015 TB Alliance and its partners ... medicines in the correct doses. The improved treatments ... set by the World Health Organization (WHO) in ... administer and affordable. The availability of these products ... by UNITAID. ...
(Date:12/1/2015)... and VANCOUVER , Dec. 1, 2015 ... OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI ) announced today ... on the pre-planned interim futility analysis of the intent-to-treat ... safety issues were identified by the DMC. Both the ... final results are expected in the second half of ...
(Date:12/1/2015)... 01, 2015 ... the "Spinal Muscular Atrophy Market - ... 2015 - 2023" report to their ... announced the addition of the "Spinal ... Growth, Trends, and Forecast 2015 - 2023" ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... According to an article published on ... claim against the U.S. Department of Health and Human Services, claiming that any states ... are breaking the clause in the law prohibiting the denial of coverage for pre-existing ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... there are professionals who believe that with innovative technologies and under the right ... patient to get the benefit of a dual-approach to his or her therapeutic ...
(Date:12/1/2015)... ... December 01, 2015 , ... It’s official: Tattoo taboo ... — a number even greater among Millennials (a whopping one in three aged 18 ... more people who are dissatisfied with their ink. In fact, RealSelf , the ...
(Date:12/1/2015)... ... December 01, 2015 , ... For the ... is why Hollister Incorporated has launched the VaPro Plus Pocket™ touch free hydrophilic ... the VaPro touch free catheter portfolio,” said Michael Gresavage, Vice President North America. ...
(Date:12/1/2015)... ... December 01, 2015 , ... Lutronic, a leading innovator of aesthetic ... addition to the devices for sale in the United States. Clarity is a ... 1064 nm Nd:YAG lasers, into a single platform that is easy to own and ...
Breaking Medicine News(10 mins):