Navigation Links
Valeant Pharmaceuticals Announces Receipt Of U.S. FDA Complete Response Letter For Efinaconazole
Date:5/28/2013

LAVAL, Quebec, May 28, 2013 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that it has received a Complete Response Letter (CRL)  from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for efinaconazole for the treatment of onychomycosis.  A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.  The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC) related areas of the container closure apparatus. As no efficacy or safety issues were raised by the FDA, Valeant believes that these items can be addressed and is working for a timely response to the FDA as soon as possible.  Valeant remains committed to bringing efinaconazole to market as a potential new treatment for onychomycosis. 

About Valeant Pharmaceuticals International, Inc.

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, neurology and branded generics. More information about Valeant Pharmaceuticals International, Inc. can be found at www.valeant.com.

Forward-looking Statements

This press release may contain forward-looking statements, including, but not limited to, statements regarding our expectation to address matters raised in the Complete Response Letter, the approval of efinaconazole and the timing of any such approval.  Forward-looking statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target", or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the uncertainty of approval of product candidates and the risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof.  Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

Contact Information:
Laurie W. Little
949-461-6002
laurie.little@valeant.com

(Logo: http://photos.prnewswire.com/prnh/20101025/LA87217LOGO )


'/>"/>
SOURCE Valeant Pharmaceuticals International, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Valeant Pharmaceuticals Agrees To Acquire AcneFree And Certain Assets From University Medical
2. Valeant Pharmaceuticals Reports 2012 First Quarter Financial Results
3. Valeant Pharmaceuticals To Host Investor Day
4. Valeant Pharmaceuticals To Announce 2012 Second Quarter Results On August 2, 2012
5. Valeant Pharmaceuticals International, Inc. Agrees To Acquire Medicis Pharmaceutical Corporation For $44.00 Per Share In Cash
6. Valeant Pharmaceuticals To Present At UBS Annual Global Life Sciences Conference
7. Valeant Pharmaceuticals Announces Management Change
8. Valeant Pharmaceuticals To Syndicate Incremental Loans
9. Valeant Pharmaceuticals Appoints Howard Schiller To Board Of Directors
10. Valeant Pharmaceuticals Announces Launch of Concurrent Private Offerings of Senior Notes
11. Valeant Pharmaceuticals International, Inc. Announces Pricing Of Concurrent Private Offerings Of Senior Notes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... March 23, 2017  Drug diversion is a ... and deadly overdoses. A new oral fluid monitoring ... www.cordantsolutions.com , reports more detailed and actionable information ... potentially improve therapy adherence, patient safety, and help ... Comprehensive Oral fluid Rx Evaluation (CORE) system is ...
(Date:3/23/2017)... 2017  The goal of the pilot is ... track prescription drugs as they are distributed in ... requirements from US FDA to better protect consumers by ... Blockchain startup Chronicled, which links the ... blockchain technology and recently raised $6.25M, and the LinkLab, ...
(Date:3/23/2017)... LONDON , March 23, 2017 ... efficacy from the TACTI-mel trial of IMP321 in combination ... in the first (1mg/kg) cohort experiencing a complete response. ... final cohort is expected to be fully recruited by ... of the AIPAC breast cancer study are expected mid-year ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... “Finding Christ Through Social ... devotional journal chronicling the writer’s path toward true communion with God. “Finding Christ ... #TruthwithGrace” is the creation of published author Lea Michelle Johnson, a follower of ...
(Date:3/24/2017)... ... , ... “Vintage and Harvest A Cultivation of Christian Love” is the creation ... North Carolina with his wife, Anna Marie. He and his wife are the proud ... also the author of “Shadow and Substance.” , “Love, the agape kind, is seen ...
(Date:3/24/2017)... ... ... Adventures of Joey, The Dog Who Barks at Puddles”: a boisterous story about a ... God intended. “The Adventures of Joey, The Dog Who Barks at Puddles” is the ... writing, especially about truth and human behavior. , Published by Christian Faith Publishing, Patti ...
(Date:3/23/2017)... Boulder, CO (PRWEB) , ... March 23, 2017 , ... ... higher bar for entry into teacher preparation programs. The NCTQ report suggests, based on ... boosting entry requirements would significantly improve teacher quality in the U.S. It argues that ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... health services to their communities, 16 more public health departments have been awarded ... decisions bring another 4.5 million people into the expanding network of communities across ...
Breaking Medicine News(10 mins):