Other safety alerts
|
| |
| The United States: FDA notification regarding isoxsuprine hydrochloride drug products |
| |
The US Food and Drug Administration (FDA) announces the final decision of the Commissioner of Food and Drugs that Vasodilan containing isoxsuprine hydrochloride lacked substantial evidence, consisting of adequate and well-controlled studies, to be effective for specific indications.
Vasodilan containing isoxsuprine hydrochloride was part of the Drug Efficacy Study Implementation process. FDA notified manufacturers and labelers of isoxsuprine hydrochloride products on 9 Aug 2021 to stop distributing their isoxsuprine hydrochloride drug products. As of 13 Oct 2021, all the companies agreed to cease distribution of the unapproved isoxsuprine hydrochloride drugs.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/fda-notification-regarding-isoxsuprine-hydrochloride-drug-products
In Hong Kong, there is no registered pharmaceutical product containing isoxsuprine hydrochloride.
Ends/Thursday, Nov 4, 2021
Issued at HKT 14:00
|
| |
