USFDA issues Qualified Infectious Disease Product status to two Wockhardt products
The Status has been granted to WCK 771 and WCK 2349.
New Delhi, August 31, 2014: The Indian drug maker Wockhardt has received Qualified Infectious Disease Product (QIPD) status on two of its drugs from the US health regulator.
The company said in a statement that two drugs - WCK 771 and WCK 2349 – received QIPD status from the US Food and Drug Administration (USFDA). It may be noted here that this is the first instance of an Indian pharma company receiving the QIPD status from USFDA.
The Status not only grants a five year extension to the drug patents in the USA but also a fast track review of the drug application. The company said that the products will be entering their global Phase-3 clinical trials early next year.
It is important to note here that the QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are identified by the Centre for Disease Control, USA, a top US government health and safety body.