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:2/23/2017)... , Feb. 23, 2017 MabVax ... oncology drug development company, announces that it has ... Administration (FDA) authorizing the initiation a Phase I ... for pancreatic cancer. MVT-1075 ( 177 Lu-CHX-A?-DTPA-HuMab5B1) is ... MabVax plans to initiate the phase I clinical ...
(Date:2/23/2017)... 23, 2017 Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT) ... oncology and dermatology biopharmaceutical company, today announced that it ... Rodrigues as special advisers to the Company,s Board ... the board on financial and corporate strategy. ... commitment of up to $2.5 million from Eric ...
(Date:2/23/2017)... Feb. 22, 2017 Medical Imaging ... imaging is performed to reveal the internal structures hidden ... the medical condition. It plays a vital role not ... as it is taken into consideration during the follow-up ... X-rays, SPECT/PET, ultrasound, CT, and MRI. For the diagnosis ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... The 89th Academy Awards will be celebrated this ... Education Policy Center Bunkum Award. We invite you to enjoy our 11th annual tongue-in-cheek ... winner is the Center for American Progress (CAP), for its report, Lessons From State ...
(Date:2/23/2017)... Hollywood, CA (PRWEB) , ... February 23, 2017 , ... ... pleased to announce that they are sponsoring a raffle. Throughout the month of February, ... Winners will receive a gift card for a dinner for two at the Cheesecake ...
(Date:2/23/2017)... ... 2017 , ... Pink Pig Publishing LLC announces the launch ... the world from different perspectives. By providing a place for people of all ... empathy, and find greater happiness. , "Our approach to structuring content is ...
(Date:2/23/2017)... VA – , ... ... coming. It’s the perfect opportunity for the nation to come ... a college basketball bracket – with its favorite fruit – ... is encouraging apple lovers to join the “Apple Madness” bracket ...
(Date:2/23/2017)... ... , ... Thomas Vas-Don suffered from severe injury due to an ... to successfully recover. In “ Origin & Insertion Charts for Massage Therapists ” (published ... of massage, anatomy , trigger points and referral pain patterns . , ...
Breaking Medicine News(10 mins):