USFDA granted QIDP status to Indian pharmaceutical firm Wockhardt
USFDA granted QIDP status to Indian pharmaceutical firm Wockhardt.
US Food and Drug Administration (USFDA) on 31 August 2014 granted Qualified Infectious Disease Product (QIDP) status to two drugs of Wockhardt, an Indian firm. The two drugs that received the QIDP are WCK 771 and WCK 2349. With this, Wockhardt became the first Indian Pharmaceutical company whose drugs have received the QIDP status.
WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet. These two drugs act against Methicillin-resistant Staphylococcus Aureus (MRSA), which causes a range of diseases from skin infection to severe respiratory infections. Besides this these two drugs have also shown potential in treatment of Hospital Acquired Pneumonia (HAP).
About QIDP status
QIDP status is granted to drug that acts against pathogens that have a high degree of unmet need in their treatment. These drugs are identified by the Centre for Disease Control, the US government’s health and safety body. This status allows fast-track review of drug applications by FDA, paving the way for an early launch.
• Wockhardt is a highly technology intensive global pharmaceutical and biotechnology company.
• It is multi-disciplinary and innovative R&D programmes globally, are strongly focused on creating Intellectual Properties.
• It has 3 research centres globally and manufacturing facilities across India, USA, UK and Ireland.