Wockhardt drug discovery gets fast track approval from USFDA

Wockhardt today said its new drug discovery programme in anti-infective research has received a major boost after two of its drugs, WCK 771 and WCK 2349, received the Qualified Infectious Disease Product (QIDP) status from the US FDA.

This is the first instance of an Indian pharmaceutical company receiving a QIDP status, Wockhardt said in a release issued here.

"This is indeed a proud moment for us. Not only does the status allow for fast track review of our drug application, it also grants a five year extension to the drug patents in USA, which is a major support for the commercial aspect of the drug. These drugs will be entering in their global Phase-3 clinical trials early next year," Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.

A QIDP status is granted to drugs, which act against pathogens that 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.

QIDP status allows for fast track review of the drug application by US FDA paving way for an early launch.

Globally, there is a significant antibiotic vacuum due to dual impact of rise in new resistant pathogens and declining research in this area, the statement said.

Over the years, Wockhardt has developed a strong anti-infective program which focuses on development of drugs which target this antibiotic gap.

Both WCK 771 and WCK 2349 act against one of the globally rising class of pathogens, MRSA (Methicillin-resistant Staphylococcus Aureus) which causes a range of diseases from the skin infection to severe respiratory infections.

In case of severe infections like Hospital Acquired Pneumonia (HAP), current medical cure has a very limited reach causing a high unmet need and mortality.


  • EPFO would do well to have better risk management of available cash

    The Employees’ Provident Fund Organisation (EPFO) is apparently revisiting its decision to invest about Rs 6,000 crore in stocks this year.


Stay informed on our latest news!


Sarthak Raychaudhuri

vice-president, HR, Asia South Whirlpool of India

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs


Amita Sharma

Smart cities for the smart citizens

The 21st century has been spoken of as the urban ...

Zehra Naqvi

The prejudiced childhood

Sometimes the most unusual things can remind you of the ...

Gautam Gupta

To read about online videos, click here

ONce, not so long ago, exhorbitant costs had made sure ...


William D. Green

Chairman & CEO, Accenture