Navigation Links
Mylan Confirms Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg
Date:8/22/2013

PITTSBURGH, Aug. 22, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) providing bioequivalence study results requested by FDA for Bupropion Hydrochloride (HCl) Extended-release (ER) Tablets USP (XL), 300 mg. Bupropion HCl ER Tablets USP (XL) are the generic version of WELLBUTRIN XL® and are indicated for the treatment of major depressive disorder (MDD).(1) Mylan launched its Bupropion HCl ER Tablets USP (XL), 150 mg and 300 mg, to the U.S. market in September 2010.

In a correspondence issued December 2012, FDA requested all generic drug companies marketing a version of Bupropion HCl ER Tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER tablets, 300 mg, to GSK's WELLBUTRIN XL (Bupropion Hydrochloride Extended-release) Tablets, 300 mg. In April 2013, Mylan submitted to FDA a sANDA containing the requested study, which demonstrated bioequivalence of Mylan's Bupropion HCl ER Tablets USP (XL), 300 mg, to WELLBUTRIN XL(R) Tablets, 300 mg.

For the 12 months ending June 30, 2013, Bupropion Hydrochloride Extended-release Tablets, 150 mg and 300 mg, had U.S. sales of approximately $503.3 million, according to IMS Health.

Currently, Mylan has 179 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

(1) Patients with a seizure disorder and pediatric patients should not take Bupropion.  Antidepressant medications have been shown to increase the risk of suicide, compared to placebo, in children, adolescents and young adults. Bupropion HCl ER Tablets USP (XL) should not be used for smoking cessation.


'/>"/>
SOURCE Mylan Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Reports a 13% Increase in Second Quarter 2013 Adjusted Diluted EPS to $0.68
2. Third Circuit Rules in Mylans Favor Regarding Paroxetine Hydrochloride Extended-Release Tablets, Sending Mylans Breach of Contract Claim Against GSK to Trial
3. Mylan to Host Investor Day on Aug. 1, 2013 in New York City
4. Roger Graham Named President of Mylan Specialty
5. Mylan Specialty L.P. Joins Forces with Adrian Peterson and Jo Frost to Launch Anaphylaxis Preparedness Campaign
6. Mylan to Speak at the Goldman Sachs 34th Annual Global Healthcare Conference
7. New Breakthroughs Allow Companies to Expand their Reach - Research Report on Perrigo, Auxilium, Actavis, Mylan, and Salix
8. Mylan Specialty L.P. Announces Partnership with Baseball Teams Across Country to Raise Awareness of Potentially Life-Threatening Allergies
9. Presenting Sponsor Mylan Specialty L.P. Calls on Communities Nationwide to Join The Food Allergy Research & Education (FARE) Walk for Food Allergy
10. Mylan Reports a 19% Increase in First Quarter 2013 Adjusted Diluted EPS to $0.62
11. Deborah Autor, FDAs Deputy Commissioner for Global Regulatory Operations and Policy, to Join Mylan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2017)... , Sept. 18, 2017 ... fields of bioinformatics and immune engineering, today ... protective avian influenza A (H7N9) vaccine. ... related to seasonal influenza and presents a ... on prior exposure to be effective. Using ...
(Date:9/12/2017)... Sept. 12, 2017   EcoVadis , the leading platform for environmental, ... first annual edition of its Global CSR Risk and Performance Index. The ... EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points across ... ... ...
(Date:9/12/2017)... FRANCISCO , Sept. 12, 2017  ValGenesis ... Management Solutions (VLMS), is pleased to announce the ... a member of its Board of Directors and ... ValGenesis VLMS enables life science companies to manage ... the use of paper in this process. Furthermore, ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
(Date:10/12/2017)... FL (PRWEB) , ... October 12, 2017 , ... On ... holding a treadmill relay – Miles by Moonlight to raise money for the American ... $300 or more. , Teams will work together to keep their treadmills moving ...
(Date:10/12/2017)... Miramar, FL (PRWEB) , ... October 12, 2017 ... ... is presenting the latest in wound care advancements to physician colleagues, skilled nursing ... lecture is titled, "Navigating the Treacherous Waters of Wound Care." , "At many ...
Breaking Medicine News(10 mins):