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Prasco Laboratories Expands Authorized Generic Product Line with Vancocin(R) HCl Capsules


4/12/2012 9:16:13 AM

CINCINNATI, April 11, 2012 /PRNewswire/ -- Prasco Laboratories announced today it will market the Authorized Generic version of Vancocin® HCl Capsules (vancomycin hydrochloride capsules, USP) in 125 mg, and 250 mg strengths in the U.S. under the Prasco label pursuant to its distribution and supply agreement with ViroPharma Incorporated (NASDAQ: VPHM). Prasco intends to launch immediately.

"We are pleased to have established this relationship with ViroPharma," said Prasco Chief Executive Officer, Chris Arington. "Consumers and pharmacists will have as one of their prescription drug choices an Authorized Generic product that provides the identical product, quality, reliability and experience as the brand."

"Prasco is the industry leader in Authorized Generics and we are pleased to have partnered with them on this project," commented Dan Soland, ViroPharma's Chief Operating Officer. "Through this partnership, patients suffering from dangerous C. difficile infections will now have access to a generic formulation of Vancocin that is identical to the brand, and proven through decades of use to be a high quality treatment for this potentially deadly disease."

Vancocin® HCl is a registered trademark of ViroPharma Incorporated.

About Vancomycin Hydrochloride Capsules

Vancomycin Hydrochloride Capsules are indicated for the treatment of C. difficile-associated diarrhea (CDAD). Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Vancomycin Hydrochloride Capsules are contraindicated in patients who have experienced a hypersensitivity to vancomycin. Vancomycin Hydrochloride Capsules must be given orally for treatment of staphylococcal enterocolitis and CDAD. Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections. Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancomycin Hydrochloride Capsules for active CDAD. Monitoring of serum concentrations may be appropriate in some instances.

Nephrotoxicity has occurred following oral Vancomycin Hydrochloride Capsules therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients. Monitor renal function. Ototoxicity has occurred in patients receiving Vancomycin Hydrochloride Capsules. Assessment of auditory function may be appropriate in some instances. Prescribing Vancomycin Hydrochloride Capsules in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. In clinical trials, the most common adverse reactions (greater than or equal to 10 percent) were nausea (17 percent), abdominal pain (15 percent), and hypokalemia (13 percent). Patients over 65 years of age may take longer to respond to therapy compared to patients less than 65 years of age. Clinicians should be aware of the importance of appropriate duration of Vancomycin Hydrochloride Capsules treatment in patients over 65 years of age and not discontinue or switch to alternative treatment prematurely.

For Vancomycin Hydrochloride Capsules prescribing information, please visit: http://www.prasco.com/downloads/Product%20PIs/66993-211-19.pdf

About Prasco

Vancomycin Hydrochloride Capsules represent the latest product from Prasco in its Authorized Generics program. Prasco provides patients, pharmacists and customers with generic options that deliver the identical brand experience. The Prasco business model encourages competition and benefits consumers through significant cost savings. Prasco sells its product line through the major distribution channels, including chains, independent pharmacies, distributors, wholesalers, and mail order pharmacies. Prasco operates from a cGMP compliant VAWD certified 160,000 sq. ft. office and warehouse facility including DEA-approved capabilities for Schedule II-V controlled drug products. For more information, visit www.prasco.com.

SOURCE Prasco


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