FDA hands back Adamis' application for an ED drug, looking for more data
The micro cap San Diego-based biotech Adamis has stumbled badly in its attempt to get a lower-cost erectile dysfunction drug on the market.
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.
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