OUR FORMULA FOR
IMPROVEMENT

We utilize the FDA’s 505(b)(2) pathway to efficiently develop improved formulations of branded reference drugs—allowing us to more cost effectively bring products to market.

To see this strategy in action, take a look at our RYANODEX® Case Study.

CASE STUDY:

RYANODEX® (dantrolene sodium)
for injectable suspension

Background:

Malignant hyperthermia (MH) is a pharmacogenetic disease that causes a fast rise in body temperature and severe muscle contractions when an affected person receives general anesthesia using volatile anesthetics or succinylcholine.

Problem:

Time delays and high fluid volumes associated with traditional MH treatment contribute to further complications during an MH crisis.

Solution:

By scrutinizing the limitations of traditional dantrolene formulations, a solution to reduce the administration time and dosing volume was discovered: RYANODEX®.

The RYANODEX® Story:

The University of Pittsburgh Medical Center (UPMC) Formulary Evaluation Team for world-renowned healthcare provider, UPMC, concluded that RYANODEX® offers “key advantages over older formulations of dantrolene” with “patient care benefits and process benefit.” As a result, in October 2014, their committee approved RYANODEX® to become the single dantrolene product stocked for their entire health network.