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:1/19/2017)... 18, 2017 The Global Therapy Partnering Terms ... to partnering deals and agreements entered into by the ... deals - Top deals by value - Deals listed ... type The report provides understanding and access to ... world,s leading healthcare companies. The report provides an ...
(Date:1/19/2017)... Va. , Jan. 18, 2017 ... the Food and Drug Administration (FDA) for its ... companies and population health decision makers can proactively ... approved products as well as emerging therapies awaiting ... largely mirrors consensus recommendations that AMCP developed during ...
(Date:1/18/2017)... and PUNE, India , January 18, ... Allied Market Research, titled, "Breast Imaging Technologies Market by Type: ... global breast imaging technologies market size was valued at $2,544 ... by 2022, growing at a CAGR of 8.4% from 2016 ... Europe together accounted for over three-fourths market ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... 19, 2017 , ... Connecticut Dermatology Group (CDG) is proud and excited to ... dermatologist. Dr. Kim brings an extensive background in cutting-edge dermatology care and research ... to welcome back Dr. Kim to the CDG team” said President and Managing Partner ...
(Date:1/19/2017)... ... 19, 2017 , ... "ProParagraph Basics is a set of ... for all media productions," said Christina Austin - CEO of Pixel Film Studios. ... paragraphs designed for multi-lined text purposes. Choose from presets with basic, yet ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... of Proctology) announced today the opening of 3 medical offices specializing specifically ... Hemorrhoids Center of Los Angeles (Beverly Hills), Hemorrhoids Center of Newport Beach, ...
(Date:1/18/2017)... , ... January 18, 2017 , ... Delaware farmer Rick ... St. Louis, Missouri. , Dickerson, of Laurel, farms about a thousand acres of soybeans, ... yellow squash on contract and pumpkins and other vegetables for the fresh market. He ...
(Date:1/18/2017)... MD (PRWEB) , ... January 18, 2017 , ... ... of Maryland Fischell Department of Bioengineering are collaborating on a research project focused ... in bioengineering, the project seeks to use nanotechnology to control the disease without ...
Breaking Medicine News(10 mins):