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Wilmington Pharmaceuticals Receives FDA Approval for Orally Disintegrating Metoclopramide Tablet
Date:9/9/2009

oduct to market."

"Wilmington Pharmaceuticals has proven to be a very reliable and efficient partner in the development of this important new dosage form of metoclopramide," Logan added.

METOZOLV ODT represents the first approved drug among an array of candidates that Wilmington Pharmaceuticals is reformulating with rapid-dissolve technology. The company identifies well-established drugs to combine with rapid-dissolve delivery technologies and then licenses the drugs to pharmaceutical partners. Wilmington's seasoned pharmaceutical executives lead an integrated network of industry experts who seamlessly execute the diverse strategies required to develop and commercialize each product.

"We take proven drugs and enhance their delivery to increase patient convenience and compliance," said David Burns, Wilmington's vice president of development and manufacturing. "We have assembled an extremely experienced and capable team that has facilitated our success in obtaining approval for METOZOLV ODT within an 18-month time frame, and the team is now developing additional products for approval."

Important Safety Information

Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.

Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.

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SOURCE Wilmington Pharmaceuticals
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