FDA Approves Sagent Pharmaceuticals' Haloperidol Injection, USP


SCHAUMBURG, Ill., Sept. 6, 2011 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced U.S. FDA approval of its Haloperidol Injection, USP, an antipsychotic medication. Sagent's haloperidol will be offered in 5 mg per mL single-dose and 50 mg per 10 mL multi-dose, latex-free vials. According to 2011 IMS data, the annual U.S. injectable market for haloperidol approximated $12.5 million. As with all products in Sagent's portfolio, haloperidol features the company's reventIV MeasuresSM packaging and labeling designed to aid in the reduction of medication errors. Sagent expects to launch the product early in the fourth quarter.

About Haloperidol Injection, USP

Haloperidol is indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.

Detailed information about the indications, warnings, complete side effect profile, and full prescribing information will be available in the package insert. Please visit www.SagentPharma.com for more information.

About Sagent Pharmaceuticals, Inc.

Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfills the evolving needs of patients.

Forward-Looking Statement

Statements contained in this press release contain forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give Sagent's current expectations and projections relating to its financial condition, results of operations, plans, objectives, future performance and business as of the date of this release. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as "anticipate," "estimate," "expect," "project," "plan," "intend," "believe," "may," "will," "should," "can have," "likely" and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Sagent's expectations are not predictions of future performance, and future results may substantially differ from current expectations based upon a variety of factors, risks and uncertainties affecting Sagent's business, including, among others, the impact of competitive products and pricing and actions by Sagent's competitors with respect thereto; the timing of product launches; compliance with FDA and other governmental regulations by Sagent and its third party manufacturers; changes in laws and regulations; and such other risks detailed in Sagent's periodic public filings with the Securities and Exchange Commission, including but not limited to Sagent's most recent quarterly report on Form 10-Q and Sagent's IPO prospectus filed on April 21, 2011. Sagent disclaims and does not undertake any obligation to update or revise any forward-looking statement in this press release, except as required by applicable law or regulation.



            

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