Romidepsin 505(b)(2) by Teva

On 13 Mar. 2020, USFDA approved Teva’s Romidepsin (505(b)(2)).

How is it different from its RLD Istodax?

Istodax^® is supplied in a kit containing two vials where API (Romidepsin) and diluents are supplied in separate vials. In Istodax^®, Romidepsin is supplied as lyophilized powder which needs to be reconstituted with supplied diluent vial.

In contrast to Istodax^®, Romidepsin by Teva is ready-to-dilute (RTD) formulation of Romidepsin where API (Romidepsin) and diluents are supplied in the single vial. Hence, no need to perform the reconstitution step.

Comparison between Romidepsin-Teva and Istodax^® is available below:

 

Want to read about new formulation approval of Pemetrexed, then click here.

Want to read more on other 505(b)(2) approvals of 2020, then click here.

List of 505(b)(2) approvals of 2019 is available here.