RALEIGH, N.C., Apr 28, 2010 (BUSINESS WIRE) -- Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO(TM) (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
In this complete response letter there are no requests for new pre-clinical or clinical trials. The sole issue raised in this letter concerns a deficiency of the manufacturing facility for this application. The manufacturer has responded to the FDA and continues to work with the FDA to resolve the matter. The facility only manufactures COLAZAL(R) Capsules and GIAZO(TM) Tablets for Salix.
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, 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 with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
Salix also markets XIFAXAN (rifaximin) Tablets, MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), OSMOPREP(R) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL(R) (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO(TM) (mesalamine) extended-release capsules 0.375 g., METOZOLV(TM)ODT (metoclopramide HCl), 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. Crofelemer, budesonide foam and rifaximin for additional indications are under development.
For full prescribing information and important safety information, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV ODT, on Salix products, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information, or contact the Company at 919 862-1000.
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 into 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: market acceptance for approved products; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; risks associated with clinical trials; our need to return to profitability; 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.
SOURCE: Salix Pharmaceuticals, Ltd.
Salix Pharmaceuticals, Ltd. Adam C. Derbyshire Executive Vice President, Finance & Administration, Chief Financial Officer 919-862-1000 or G. Michael Freeman Associate Vice President, Investor Relations and Corporate Communications 919-862-1000 Copyright Business Wire 2010
