FDA Issues Complete Response Letter on SEFELSA™ New Drug Application

     FDA Issues Complete Response Letter on SEFELSA™ New Drug Application

PR Newswire

NEWARK, Calif., May 31, 2013

NEWARK, Calif., May 31, 2013 /PRNewswire/ --Depomed, Inc. (Nasdaq: DEPO), a
specialty pharmaceutical company, announced today that the U.S. Food and Drug
Administration (FDA) issued a complete response letter (CRL) to the New Drug
Application for SEFELSA, Depomed's investigational, oral, twice daily
formulation of gabapentin^to treat moderate to severe vasomotor symptoms due
to menopause.

The CRL states that the FDA cannot approve the application in its present
form. Based on the letter, Depomed does not currently intend to further
invest in SEFELSA.

"The CRL was expected in light of the SEFELSA FDA Advisory Committee meeting,"
said Jim Schoeneck, President and Chief Executive Officer."Depomed today is a
product-focused, growth-oriented specialty pharmaceutical company with
revenues from two marketed products, Gralise and Zipsor, significant royalty
income from our partnered products and technology, a strong balance sheet and
potential to turn cash flow positive in the second half of this year." 

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 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
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 and  Quarterly Report on Form 10-Q for the quarter ended March 31,
2013. 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.

CONTACTS:

August J. Moretti
Depomed, Inc.
510.744.8000

SOURCE Depomed, Inc.

Website: http://www.depomed.com
 
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