Navigation Links
Par Pharmaceutical Receives Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg
Date:8/20/2013

WOODCLIFF LAKE, N.J., Aug. 20, 2013 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) for bupropion hydrochloride (HCl) extended-release (ER) tablets USP (XL), 300 mg.  Bupropion HCl ER tablets USP (XL) is the generic version of WELLBUTRIN XL® and is indicated for the treatment of major depressive disorder (MDD).  Par's supply to the market of bupropion HCl ER tablets USP (XL), 150 mg and 300 mg, has been uninterrupted since originally approved in December 2006. 

In September 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 December 2012, Par submitted a sANDA containing the requested study to FDA, which demonstrated in vivo bioequivalence of Par's bupropion HCl ER tablets USP (XL), 300 mg, to WELLBUTRIN XL® Tablets, 300 mg.  In April 2013, Par's sANDA was approved. 

Important Information About Bupropion HCl ER Tablets (XL) 
Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder, in patients treated with ZYBAN® (bupropion hydrochloride extended-release tablets (XL)); WELLBUTRIN® (bupropion hydrochloride tablets), the immediate-release formulation; WELLBUTRIN SR® (bupropion hydrochloride extended-release tablets (SR)), the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent, in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion, and in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines). 

The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated.  At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL). 

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL). 

A black box warning is associated with this product regarding Suicidality and Antidepressant Drugs.  Refer to full prescribing information for complete boxed warning. 

About Par Pharmaceutical Companies, Inc. 
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals.  For press release and other company information, visit www.parpharm.com


'/>"/>
SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Ferring Pharmaceuticals Provides Baby Quest Foundation Grant Recipients with Free Access to Fertility Medication
2. Johnson & Johnson Completes Acquisition Of Aragon Pharmaceuticals, Inc.
3. HedgePath Pharmaceuticals, Inc. Completes Reorganization Plan with Commonwealth Biotechnologies
4. National Pharmaceutical Council Studies New Formulary Decision-Making Tool
5. TetraLogic Pharmaceuticals Announces New Executives
6. Selexys Pharmaceuticals Initiates SUSTAIN Phase 2 Clinical Trial in Sickle Cell Patients with Pain Crises
7. Velocity Pharmaceutical Development and Remeditex Ventures Announce Collaboration Agreement and Initial Co-Investment
8. Pharmaceutical Companies Can Avoid Costly Launch Expenses by Leveraging and Pooling Sales and Promotional Resources
9. Cadence Pharmaceuticals Comments on USPTOs Non-Final, Initial Office Action on Reexamination of Patent
10. Japan Pharmaceutical Market Outlook
11. Cadence Pharmaceuticals Appoints Laureen DeBuono to its Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/13/2017)... , Sept. 13, 2017   OrthoAtlanta has been ... Atlanta Football Host Committee (AFHC) for the 2018 College Football ... 8, 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... the AFHC "I,m In" campaign, participating in many activities leading ... ...
(Date:9/12/2017)... , Sept. 12, 2017  Consumer reviews on the independent review ... as the number one company for hearing aids, ranking it higher ... other brands. ... Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high performance, state-of-the-art, ...
(Date:9/9/2017)... 8, 2017 ... Unit coming to Washington DC ... When: Tuesday, September 12 th – Monday, September 18 th .The ... free MRI brain scans to the public.Where:  BTF,s ... at 501 K Street NW, Washington, D.C.What:BTF brings its nationwide initiative, the ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... WILMINGTON, Del. (PRWEB) , ... October 12, 2017 ... ... technology and advisory services for healthcare compliance program management, will showcase a range ... and National Association for Assisted Living (NCAL) Convention and Expo to be held ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed a ... and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been ... standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... in post-acute health care, have expanded their existing home health joint venture through ... AccentCare has been operating a joint venture home health company with Asante, delivering ...
Breaking Medicine News(10 mins):