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Roxane Laboratories, Inc. Announces the Abbreviated New Drug Application Approval of Valacyclovir Hydrochloride Tablets 500mg and 1g


6/10/2010 8:38:54 AM

COLUMBUS, Ohio, June 9 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the Abbreviated New Drug Application (ANDA) approval of Valacyclovir Hydrochloride Tablets 500mg and 1g as of May 24, 2010 by the Food and Drug Administration. Valacyclovir Hydrochloride Tablets are a nucleoside analogue DNA polymerase inhibitor indicated for use in adult patients for the following: Cold Sores (Herpes Labialis), Genital Herpes (treatment of initial or recurrent episodes in immunocompetent patients, suppression in immunocompetent or HIV-infected patients, and reduction of transmission), and Herpes Zoster. Valacyclovir Hydrochloride Tablets are also indicated for use in pediatric patients for the treatment of Cold Sores (Herpes Labialis). The efficacy and safety of Valacyclovir Hydrochloride Tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients. Roxane Laboratories, Inc. Valacyclovir Hydrochloride Tablets 500mg and 1g, bottles of 30 are available for immediate shipment to wholesalers and pharmacies nationwide.

(Photo: http://photos.prnewswire.com/prnh/20100609/CL18759 )

(Photo: http://www.newscom.com/cgi-bin/prnh/20100609/CL18759 )

Roxane Laboratories' Valacyclovir Hydrochloride Tablets 500mg and 1g bottles of 30 are AB rated to VALTREX® (valacyclovir hydrochloride tablets). Annual sales of Valacyclovir Hydrochloride Tablets 500mg and 1g are approximately $2.13 BN(1) .

Full prescribing information for Valacyclovir Hydrochloride Tablets 500mg and 1g is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.

VALTREX® is a registered trademark of GlaxoSmithKline.

About Roxane Laboratories, Inc.

Roxane Laboratories, Inc. is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories, Inc. markets more than 75 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.

Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com

(1) IMS, USA MAT dollar sales ending December 2009

SOURCE Roxane Laboratories, Inc.



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