FDA hands back Adamis' application for an ED drug, looking for more data

FDA hands back Adamis' application for an ED drug, looking for more data

Source: 
Endpoints
snippet: 

The specialty pharmaceutical company — which focuses on developing cheaper drugs for various disorders — said the FDA had deemed its marketing application incomplete, handing back the application with a refusal-to-file notice and indicating the biotech did not include sufficient data to permit review. The experimental drug is a fast-disintegrating sublingual version of tadalafil.