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.
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.
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
SOURCE Depomed, Inc.