Innovative drug amlodipine besylate oral solution lyophilized powder approved for marketing by the US FDA
August 1, 2025
Source: drugdu
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On July 29, Changchun High-Tech announced that its controlled subsidiary, Beilinian, had received marketing approval from the U.S. Food and Drug Administration (FDA) for its lyophilized powder for oral solution of amlodipine besylate. This lyophilized powder is a modified version of Beilinian's 505B2 innovative drug for children aged six and older and adults with hypertension and dysphagia. It can lower blood pressure in children and adults aged six and older, and reduce the risk of fatal and non-fatal cardiovascular events. This approval will enrich Beilinian's product portfolio in the U.S. and enhance the company's competitiveness in the pharmaceutical market.
The FDA approval of this product is a positive attempt by Changchun High-Tech to export its improved innovative drugs overseas, demonstrating that the company has certain international registration and improved drug development capabilities.
Source：https://www.yinsfinance.com/article/1393884.shtml
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