Navigation Links
Trading of Depomed Common Stock Halted
Date:3/4/2013

NEWARK, Calif., March 4, 2013 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) announced that NASDAQ has halted trading of the company's common stock. The U.S. Food and Drug Administration's (FDA) Reproductive Health Drugs Advisory Committee is meeting this morning to discuss the company's New Drug Application (NDA) for SEFELSA™, Depomed's investigational, oral, twice daily formulation of gabapentin, to treat moderate to severe vasomotor symptoms due to menopause.  SEFELSA is the proposed trade name for the medication and was formerly referred to as Serada.

The Prescription Drug User Fee Act (PDUFA) date for SEFELSA is May 31, 2013.  The PDUFA date is the goal date for the FDA to complete its review of the NDA.

Conference Call

Depomed will host a conference call later today, Monday, March 4 to discuss the Advisory Committee recommendation.  The specific start time for the call will be announced later today.  Participants can access the call by dialing 877-317-6789 (United States) or 412-317-6789 (international). The conference call will also be available via a live webcast on the investor relations section of Depomed's website at http://www.depomed.com. Access the website 15 minutes prior to the start of the call to download and install any necessary audio software. An archived webcast replay will be available on the Company's website for three months.

About Depomed

Depomed, Inc. is a specialty pharmaceutical company with three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN).  Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults.   Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed has also submitted a New Drug Application to the FDA for SEFELSA (proposed trade name), a non-hormonal investigational product for menopausal hot flashes.  The company formulates its products and product candidates with its proven, proprietary Acuform® drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.  The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to regulatory approval of our product candidates and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K for the year ended December 31, 2012.  The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

CONTACT: August J. Moretti  
Depomed, Inc. 510.744.8000
amoretti@depomed.com


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

Related medicine technology :

1. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
2. American Oriental Bioengineering Inc. Announces Suspension of Trading in its Common Stock and the Initiation of Delisting Proceedings by NYSE
3. Trading Of Onyx Pharmaceuticals Common Stock Halted
4. K-V Pharmaceutical Class A and Class B Common Stock Begin Trading on the OTC Markets
5. Angeion Announces Name Change and New Trading Symbol Effective Tuesday, August 21, 2012
6. Sae-A Trading Sponsors Medical Mission to Haiti
7. Generex Addresses Recent Trading Volume in Shares of its Common Stock
8. SafeCode Drug Technologies Corp. Begins Trading on the Over-the-Counter Bulletin Board
9. MetaStat Announces Stock Trading on OTC Bulletin Board
10. Vasomedical Common Stock Commences Trading on the OTCBB
11. Depomed Announces Receipt of $1 million Milestone Payment From Ironwood Pharmaceuticals, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... N.J. , Dec. 5, 2016  Daiichi ... preliminary safety and efficacy data from a phase ... MDM2 inhibitor, suggesting that DS-3032 may be a ... myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). ... the phase 1 study of DS-3032 were presented in ...
(Date:12/5/2016)... -- BD (Becton, Dickinson and Company) (NYSE: BDX ... an enhanced technology platform designed with the ability to ... Pyxis™ and Alaris™ systems, at this year,s American ... being held in Las Vegas ... that approximately 68 percent of medication errors occur during ...
(Date:12/5/2016)... , Dec. 5, 2016 Eisai Inc. ... at the 2016 Annual Meeting of the American Epilepsy ... CIII, is indicated as an adjunctive therapy for the ... secondarily generalized seizures and primary generalized tonic-clonic seizures (PGTC) ... age and older. Please see Important Safety Information for ...
Breaking Medicine Technology:
(Date:12/6/2016)... ... December 06, 2016 , ... It can be argued that people these days ... members as they do for their human friends and family. As pets have ... highest quality and most innovative pet products has also increased. , For ...
(Date:12/6/2016)... ... December 06, 2016 , ... The Behavioral Health Center ... recognizing the organization as a top behavioral service provider in the country. The ... quality, staff satisfaction and qualifications, and consumer satisfaction. These areas are measured via ...
(Date:12/6/2016)... ... December 06, 2016 , ... Gateway Analytical, one of ... particle counting and sizing services for USP 788 and 789 particulate standards compliance. ... as a response to the needs of pharmaceutical and medical device manufacturers, who ...
(Date:12/6/2016)... ... December 06, 2016 , ... ... the much-anticipated HydroFX for Water®. This first-of-its-kind water-soluble powder supplement has a ... world’s most powerful antioxidants, molecular hydrogen, HydroFX for Water transforms every day ...
(Date:12/6/2016)... Vancouver, B.C., Canada (PRWEB) , ... December 06, ... ... Consultants (STC) announce the availability of the newly updated International Audit Protocol Consortium ... world use IAPC EHS audit protocols to understand the scope of their EHS ...
Breaking Medicine News(10 mins):