Wockhardt Gets Coveted Status from U.S. Regulator for Antibiotic Drug

Wednesday, 09 December 2015, 10:37 Hrs
41
cmt right
48
Comment Right
87
cmt right
16
cmt right
Printer Print Email Email


NEW DELHI: A new antibiotic drug by pharmaceutical major Wockhardt has been conferred the status of qualified infectious disease product (QIDP) by the United States Food and Drug Administration (FDA).



The company received the coveted status for the antibiotic named 'WCK 5222', a product from its new drug discovery programme in anti-infectives, Wockhardt said in a filing to the BSE.



"We are pleased that WCK 5222 has received the QIDP status, which is fourth for the company in quick succession," said Wockhardt chairman Habil Khorakiwala.



"The company's relentless focus for almost two decades in the anti infective space has started showing recognition with consecutive approvals for QIDP in quick succession," Mr Khorakiwala added.



WCK 5222 is a new class of antibiotic for "gram negative terrain" for complicated urinary tract infections and hospital acquired bacterial pneumonia, the company added.



Mr Khorakiwala claimed that when 5222 is approved, it will save many lives worldwide.



He added there was a global crisis of availability of antibiotics to fight resistant bacteria and there had been a huge void in anti infectives as relatively very few drugs had been discovered in the past decade.



The QIDP status is granted to drugs identified by Centre for Disease Control, U.S, 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 US health regulator for drug approval and a five-year extension of market exclusivity after product approval in the U.S.
Also Read:
BabyChakra Introduces a ChildCare APP for Young Parents
Surge in Diabetes Can Hamper India's Economic Growth


Source: PTI
SPOTLIGHT
Finance
India's tea exports increased by 11.5 per cent to 17.93 million kgs in April this year aga..
Business
Automobile major MG Motors India on Wednesday said that it plans to manufacture electric vehicle E..
Career
Les Roches Global Hospitality Education, a multi-national hospitality management institute, a..
Gadgets
Yamaha Music India has launched its first Indian keyboard PSR I500 under the 'Make in India' initi..
Startup City
With cities growing rapidly and infrastructure not keeping pace, the daunting work com..
Enterprise IT
Taking on streaming giants like Netflix and Hulu, Walt Disney Co. has announced it will ..
Technology
To ensure uninterrupted functioning of the app in areas of low networks, Facebook-owned..
Travel
Imagine life being a romantic Bollywood song of the 90's. All those exotic frames punched into one..
Entertainment
Actor Dhanush, whose last Hindi release was R. Balkis "Shamitabh", may be working in another H..