Dr Reddy's Laboratories has reportedly run into trouble with the US health authorities for not highlighting important risk information on a promotional website for injectable generic fondaprinux sodium.
According to reports, failure to provide adequate warning about the risk of using the USP for injections was raised by the Department of Health and Human Services, under the USFDA. The authority directed the company to submit its reply to the finding on or before January 12. However, it is not clear whether the company has furnished its response to the USFDA .
Dr Reddy's has been requested by OPDP to immediately halt the dissemination of violative promotional materials for fondaparinux sodium such as the promotional website, reports added.