News: ACR Acrux Posts FY Net Loss After Tax A$14.2 Mln, page-5

The GDUFA was introduced in October, 2012 (and re-authorized for a further 5 years in 2017) to expedite the FDA review process for getting generic drugs to market.

It essentially involves the drug companies paying a fee to the FDA to accommodate the speedier process. In the case of an ANDA submission it's US$178,799 for FY19.

Despite the fees, the reduced review timelines are really a win-win for both consumers and the drug industry as the generic product can reach the market faster by a period measured in years.