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Sagene Pharmaceuticals, Inc. Announces FDA Approval of Clindamycin Injection, USP


10/3/2011 6:40:55 AM

SCHAUMBURG, Ill., Sept. 30, 2011 (GLOBE NEWSWIRE) -- Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT - News) today announced U.S. FDA approval of Clindamycin Injection, USP, an antibiotic used to treat bacterial infections. Sagent's latex-free clindamycin will be available in three single-dose vial sizes and in pharmacy bulk packaging. According to IMS, the 2011 U.S. market for injectable clindamycin approximates $65 million. Sagent expects to launch the product in early 2012. As with all products in Sagent's portfolio, clindamycin features the company's PreventIV MeasuresSM packaging and labeling designed to aid in the reduction of medication errors.

Clindamycin is the twelfth product approved under the joint venture between Sagent and Strides Arcolab. Under the collaboration, Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.

About Clindamycin Injection

Clindamycin is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria.

It is also indicated for the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.

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.

About Strides Arcolab, Ltd.

Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across six countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company's website at www.stridesarco.com.

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.

Contact:

INVESTOR CONTACT:Ronald Pauli, Sagent(847) 908-1604MEDIA CONTACT:Kelly Davisson, WCG(312) 646-6297




   

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