FDA Grants Qualified Infectious Disease Product Status to Two Anti-Infectives
Wockhardt Limited announced that the FDA has granted Qualified Infectious Disease Product (QDIP) status to WCK 771 and WCK 2349, two drugs that are a part of the New Drug Discovery program in Anti-Infective research.
According to Dr. Habil Khorakiwala, Wockhardt Founder and Chairman, “These two drugs act against Methicillin-resistant Staphylococcus Aureus (MRSA) and have shown potential in the treatment of Hospital Acquired Pneumonia (HAP). WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, which is a significant for the drug development scenario as currently there is very little advanced drug research in developing solid oral dosages. Most of the research is in developing intravenous drugs which requires significantly higher medical attention and increased rate of hospitalization wherein the chances of catching other infections is very high."
Wockhardt plans to initiate its global Phase 3 clinical trial early next year.
For more information visit Wockhardt.com.