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

PITTSBURGH, May 4 /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 Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban®.  

Bupropion HCl ER Tablets had U.S. sales of approximately $9.7 million for the 12 months ending Dec. 31, 2009, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 140 ANDAs pending FDA approval representing $96.5 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.6 billion in annual brand sales, for the 12 months ending Dec. 31, 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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Receives Approval for Generic Version of Flomax(R)
2. Mylan Schedules First Quarter 2010 Financial Results Conference Call and Live Webcast
3. Mylan Receives Approval for Generic Version of Actigall(R)
4. Mylan Awarded NABP-VAWD Accreditation for Its Primary North American Distribution Facility
5. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
6. Mylan Receives Approval for Generic Version of GoLytely(R)
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
9. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
10. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
11. Mylan Added to NASDAQ-100 Index
Post Your Comments:
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... of the "Self Administration of High Viscosity ... ) has announced the addition of ... report to their offering. --> ... the addition of the "Self Administration of ...
(Date:11/25/2015)... total global healthcare industry is expected to grow at a ... has the highest projected growth at 12.7%, and ... ), is second with growth projected at 11.5%. ... In 2013-2014, total government funded healthcare was nearly 68%. Federal ... in 2013-2014. In real terms, out of pocket expenditure increased ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... The ... and prominent nonprofit healthcare organizations in the country. They have overseen financial turnarounds, ... and helped advance the healthcare industry as a whole through their advocacy and ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
(Date:11/26/2015)... ... ... PRMA Plastic Surgery is updating their record books yet again with an ... breast reconstruction surgery! , “What an accomplishment for the PRMA team, says Dr. ... an honor to have served all of these women.” , PRMA is one of ...
(Date:11/25/2015)... ... November 25, 2015 , ... Additional breast cancers ... on mammography, according to a study published online in the journal Radiology. Researchers ... mammography may necessitate a change in treatment. , Breast MRI is the most ...
(Date:11/25/2015)... ... 25, 2015 , ... TyloHelo Inc , North America’s ... Sauna accessories help improve the bather experience in the sauna, and the accessories ... the purist looking for simplicity in design to accessories that encourage a greater ...
Breaking Medicine News(10 mins):