01 Jul 2012 – Generating Antibiotic Incentives Now (GAIN) Act passed by US Senate on 26th June 2012

The “Generating Antibiotic Incentives Now (GAIN) Act provides incentives
for pharmaceutical companies to develop new antibiotics/antibacterial
drugs for the treatment of life-threatening infections caused by multi-drug
resistant bacteria, such as methicillin-resistant Staphylococcus
(MRSA), vancomycin-resistant Staphylococcus and enterococcus,
Acinetobacter, Klebsiella, Pseudomonas, E. coli, multi-drug resistant
Tuberculosis, and Clostridium difficile. Under the GAIN Act Qualified
Infectious Disease Products (“QIDPs”) intended to treat serious or life-threatening
bacterial infections may benefit from the following incentives:

  • 5 Years additional US Market Exclusivity
  • Priority FDA Review reducing from 12 to 8 months
  • Fast Track Status

For further information please click on the link here

Leave a Reply

Your email address will not be published. Required fields are marked *