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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
RALEIGH, NC, USA | May 16, 2008 | 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.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com or contact the Company at 919–862–1000. Information on our web site is not incorporated in our SEC filings.
SOURCE: Salix Pharmaceuticals, Ltd. |
