Salix Pharmaceuticals, Ltd (NASDAQ:SLXP), Valeant Pharmaceuticals Intl Inc (NYSE:VRX) and Actavis Laboratories greatly understand the major discomfort that patients suffering from the irritable bowel syndrome have been experiencing and are laying down important strategies to help.
Their joint act of staying outstanding in line with the litigation regarding Actavis’ application for approval of a generic version of Xifaxan has sparked high talk worldwide. Xifaxan is expected to rise through the ranks to become one of the most reliable forms of treatment for bowel syndrome.
The other thing is about the parties coming together with the common goal to actually extend the 30-month stay on the litigation. According to some close sources, Valeant had at an earlier time filed a Citizen Petition and as a matter of fact that was done with the U.S. Food and Drug Administration in October. The high end provider hoped that it would manage to obtain to obtain the much needed changes in regards to the previously recommended standards for approval of generic versions of Xifaxan.
One thing that is for sure is the fact that indeed Xifaxan is for sure the top selling drug from Valeant and according to the company’s financial executives; it has been able to fetch about $1 billion in the past in term of the associated annual sales.
Citizen petition as a matter of fact happens to be a process that creates room for the different drug providers as well as companies to move ahead and seek the changes they need in line with the FDA health policy.
In a latest statement, Valeant outlined, “On March 16, 2017, the FDA answered the Citizen Petition and issued its revised draft guidance regarding the recommended standards for approval of ANDAs for generic versions of Xifaxan. Valeant remains confident in the strength of the Xifaxan patents and will defend its intellectual property vigorously,”
To rise up to the top to become an industry leader, it of course talks much dedication to work as well as a proper allocation of resources. One of the company’s top executives while speaking to news reporters said that the company had over the years channeled its resources the right way and that has contributed to Valeant becoming what it is in the present.