Salix Pharmaceuticals Receives Approvable Letter from FDA for Balsalazide Tablet

RALEIGH, N.C.--(Business Wire)--
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the
Company has received an approvable letter from the U.S. Food and Drug
Administration (FDA) for balsalazide tablet studied as a treatment of
mild-to-moderate active ulcerative colitis in patients 18 years and
older.

"Late this afternoon Salix received a communication from the FDA
that the Balsalazide Tablet NDA is approvable," stated Bill Forbes,
Pharm.D., Vice President, Research and Development, and Chief
Development Officer. "Salix will work diligently with the FDA over the
next several days to compile a complete response to this approvable
letter, which Salix believes will consist of referencing data already
available."

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North
Carolina, develops and markets prescription pharmaceutical products
for the treatment of gastrointestinal diseases. Salix's strategy is to
in-license late-stage or marketed proprietary therapeutic drugs,
complete any required development and regulatory submission of these
products, and market them through the Company's gastroenterology
specialty sales and marketing team.

Salix markets COLAZAL(R) (balsalazide disodium) Capsules 750 mg,
XIFAXAN(R) (rifaximin) tablets 200 mg , OSMOPREP(R) (sodium phosphate
monobasic monohydrate, USP and sodium phosphate dibasic anhydrous,
USP) Tablets, MOVIPREP(R) (PEG 3350, Sodium Sulfate, Sodium Chloride,
Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral
Solution), VISICOL(R) (sodium phosphate monobasic monohydrate, USP,
and sodium phosphate dibasic anhydrous, USP) Tablets, PEPCID(R)
(famotidine) for Oral Suspension, Oral Suspension DIURIL(R)
(Chlorothiazide), AZASAN(R) Azathioprine Tablets, USP, 75/100 mg ,
ANUSOL-HC(R) 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC(R) 25 mg
Suppository (Hydrocortisone Acetate), PROCTOCORT(R) Cream
(Hydrocortisone Cream, USP) 1% and PROCTOCORT(R) Suppository
(Hydrocortisone Acetate Rectal Suppositories) 30 mg. Vapreotide
acetate, balsalazide tablet, granulated mesalamine and XIFAXAN(R) for
additional indications are under development.

For full prescribing information on Salix products, please visit
www.salix.com or contact the Company at 919 862-1000.

Salix trades on the NASDAQ Market under the ticker symbol "SLXP."

For more information please visit our web site at www.salix.com .
Information on our web site is not incorporated in our SEC filings.

Please Note: The materials provided herein contain projections and
other forward-looking statements regarding future events. Such
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to differ
materially. These risks and uncertainties include, among others: the
unpredictability of the duration and results of regulatory review of
New Drug Applications and Investigational NDAs; the possible
impairment of, or inability to obtain, intellectual property rights
and the costs of obtaining such rights from third parties; generic and
other competition; our need to return to profitability; the high cost
and uncertainty of the research, clinical trials and other development
activities involving pharmaceutical products; market acceptance for
approved products and the need to acquire new products. The reader is
referred to the documents that the Company files from time to time
with the Securities and Exchange Commission.

Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Senior Vice President and
Chief Financial Officer
or
Mike Freeman, 919-862-1000
Executive Director, Investor Relations and
Corporate Communications

Copyright Business Wire 2008