(Photo courtesy: http://allphasepharma.com)
Wockhardt has announced that United States Food and Drug Administration (USFDA) has granted WCK 5222, a product from their breakthrough new drug discovery program in anti infectives, Qualified Infectious Disease Product (QIDP) status.
Dr Habil Khorakiwala, Wockhardt chairman, said, "We are pleased that WCK 5222 has received the QIDP status, fourth for the company in quick succession. WCK 5222 is a new class of antibiotic for gram negative terrain for complicated urinary tract infections and hospital acquired bacterial pneumonia."
QIDP status is granted to drugs identified by Centre for Disease Control, US, that act against pathogens which have a high degree of unmet need in their treatment.
The status provides fast track clinical development and review of the drug application by the USFDA for drug approval and a five year extension of market exclusivity post product approval in the US.