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:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):