25 July 2016 - As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US FDA is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications.
The new data (up to 1 July 2016) reveals that FDA has reduced its abbreviated new drug application (ANDA) workload by about 500 applications in the first six months of 2016. The agency has also approved 315 more ANDAs over that same time period and sent 66 more complete responses (or rejections) for industry action.